MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-42-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Adhesion(s) (1695); Cellulitis (1768); Hearing Impairment (1881); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Tinnitus (2103); Vertigo (2134); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised due to loosening at bone to implant interface and disengaged of the bipolar head to poly insert in the post-op event.Doi: (b)(6) 2022; dor: (b)(6) 2022; affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received: a.Affected side: b.Was there a surgical delay? what was the duration of the delay? c.Please confirm the revision date.D.Was there adverse symptoms experiencing by the patient which led to revision? e.Was the femoral head coming out of the self-centering head poly liner, or was the poly in the self-centering head coming apart from the self-0centering metal part itself? a.Left b.No c.4/21 d yes instability e poly liner out of bipolar head.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6b and h6 (clinical code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H6 medical device problem code: device dislodged or dislocated (a051201) captures locking mechanism and hip.E3 initial reporter occupation: lawyer.

Event Description

In addition to what previously alleged, records alleges pain, traumatic hip failure, difficulty walking, limitation of daily activities, bodily injury, disability, scarring, disfigurement, and mental anguish.During the revision it was confirmed that bipolar head was completely displaced from the outer shell.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Left hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a5, a6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.After review of the medical records, the patient has had a series of follow-up eent visits; on (b)(6) 2014, the patient presented with dizziness, giddiness, cerumen impaction, hearing loss, and vertiginous syndrome.On (b)(6) 2014, the patient presented with a swelling mass/lump head/neck and labyrinthine dysfunction.On (b)(6) 2014, the patient continued to present cerumen impaction and hearing loss.In the succeeding years thereon, the patient presented with hearing loss.With impacted cerumen bilateral and tinnitus bilateral.On the (b)(6) 2021 patient was diagnosed with conductive hearing loss bilateral and rheumatoid arthritis.On (b)(6) 2022, the patient presented pain on a scale of 6/10 and worse when her feet hit the ground.The patient has post shingles from 40 years ago, pain in her back and hips, and she has had three hip replacements in three years, in 2019 and two in 2022 because the device inserted became defective.In 2022 she had an mri of her spinal column and x-rays.The patient does pt four times a week and exercises 45 minutes a day.The patient states she used ice for back pain.The patient stated she was having groin pain.She had a hip revision due to hardware failure.She was walking with a walker.She was also diagnosed with cellulitis.She is scheduled to have a left thr on (b)(6) 2023.There was no recent falls reported.The patient was in opioid treatment.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After a review of the medical records clinical visit reported recurrent of skin cancer & detect a new lesion of the left tibial or bowen's disease and a scaly left leg.However, there is no information that correlates the hip implants and procedures contribute to this skin cancer and new lesion mention.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received: on (b)(6) 2011, the patient had an ultrasound retroperitoneum, complete for diagnosis of urinary tract infection.Identified bilateral renal cysts, and 3.5 mm kidney stone or angiolipoma of the right kidney.There is no evidence that this is related in any fashion to the depuy hip products or the implantation procedure.On (b)(6) 2015, a ct scan of the head without contrast was due to a patient presenting with headaches following a fall, striking the head.The impression is atrophy and white matter changes consistent with the patient's age, with no acute lesions identified.There is no evidence that this is related in any fashion to the depuy hip products or the implantation procedure.On (b)(6) 2015, an mri exam from (b)(6) 2015 was reviewed, the cervical spine (without contrast) for diagnosis of cervical spondylosis.Identified posterior disc bulging with posterior osteophytes, but no evidence of neural foraminal or spinal stenosis, at c3 thru c7.Also, a mild pannus identified is observed, adjacent to the odontoid.There is no evidence that this is related in any fashion to the depuy hip products or the implantation procedure.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence found that the neck of stem appears to be in unintended contact with the edge of the cup.Based on the observations, it is not unreasonable to conclude that the poly insert disassociated from the metal cup.The dislocation event was not confirmed based on the provided information.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SELF CENT HIP 42X28 RUST
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14192284
• MDR Text Key: 289955323
• Report Number: 1818910-2022-07385
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003328
• UDI-Public: 10603295003328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-42-000
• Device Catalogue Number: 103542000
• Device Lot Number: JG4772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL AMT SZ10 135 LOW COL; SELF CENT HIP 42X28 RUST
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White