MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-710

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 05/19/2022

Event Type  Injury  

Event Description

This complaint was created in relation to aei note a-(b)(4) under pc-(b)(4) stated that pc-(b)(4) medical records ad (b)(6) 2023 (1) (1).Pdf pc-(b)(4) medical records ad (b)(6) 2023 (2).Pdf pc-(b)(4) medical records ad (b)(6) 2023 (5).Pdf, was reviewed by clinician.On (b)(6) 2009, the patient had a right total hip arthroplasty to address advanced degenerative arthritis of the right hip.Depuy components were implanted during this procedure.Sticker page 25 of 33 in pc-(b)(4) medical records ad (b)(6) 2023 (2).On (b)(6) 2021, the patient had a revision right hip to address failed right metal on metal hip replacement, abductor tear.The patient reported having progressive right hip pain, and elevated cobalt levels and a preop mri was noted to show pseudotumor with abductor tear.During the procedure the observed that the patient¿s tissue was hypertorphic and very fibrous.There was a significant corrosion on the trunnion.There was a grayish tint to the tips of the abductor and the metal debris was removed.There was osteolysis.The metal head and metal liner were revised.Depuy poly liner and depuy ceramic biolox delta head was implanted.Part/lot on page 1 of 3 on pc-(b)(4) medical records ad (b)(6) 2023 (4).(pc-(b)(4)).On (b)(6) 2022, the patient had a revision right arthroplasty to address unstable right hip.Depuy constrained liner and depuy biolox femoral head were implanted during this procedure.The patient was noted to have issues with instability.The patient has significant abductor deficiency which is why the surgeon decided to revise to constrained liner.During the procedure the surgeon observed the subfascial tissue showed significant devitalized tissue that was gray color.Part/lot page 1 of 2 pc-(b)(4) medical records ad (b)(6) 2023.Doi: (b)(6) 2021.Dor: (b)(6) 2022.(right hip).

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

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: h6 (clinical code) 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 : the device associated with this report was not returned to depuy synthese for evaluation.Review of the x-ray evidence confirm the reported allegation.Based on the position of the femoral head regarding the cup, a dislocation event between the liner and femoral head was able to be confirmed.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.

Event Description

On (b)(6) 2009, the patient had a right hip arthroplasty, to address advanced degenerative arthritis.On (b)(6) 2021, the patient had a right hip revision, to address failed right metal-on-metal hip replacement, and abductor tear.Indications for surgery included pain, elevated chromium 1.0 and elevated cobalt 9.4, and torn abductors.There was a significant amount of corrosion on the trunnion, there was metal wear debris, and there was osteolysis.The metal liner/head was revised to a ceramic head and poly liner.On (b)(6) 2022, medical records note the patient reports having right hip fatigue capture on (b)(4).On (b)(6) 2022, patient had a closed reduction of dislocated hip capture on (b)(4).On (b)(6) 2022, the patient had a revision of the right tha, to address an unstable hip arthroplasty.It was noted that the patient had dislocated three times prior to revision.During the revision, the surgeon observed that the tissue was gray in color.Depuy poly-constrained liner as well as depuy biolox were implanted during this procedure.On (b)(6) 2022, the patient had an arthrocentesis right trochanteric bursa due to pain, and the right side greater trochanteric bursa.On (b)(6) 2022, the patient reports having back pain, right hip pain, and right leg pain on (b)(6) 2023, the patient reports having pain in the lower back, with radiation to the right groin.There is associated chronic right leg weakness that continues to worsen and bilateral feet numbness and tingling.The patient has completed extensive physical therapy.

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.

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.

• Brand Name: DLT TS CER HD 12/14 32MM +1
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16654903
• MDR Text Key: 312434689
• Report Number: 1818910-2023-07024
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295033462
• UDI-Public: 10603295033462
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-710
• Device Catalogue Number: 136532710
• Device Lot Number: 9639434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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: ALTRX +4 NEUT 32IDX50OD; DLT TS CER HD 12/14 32MM +1; PINNACLE 100 ACET CUP 50MM; SUMMIT DUOFIX TAP SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White