MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-02-100

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Depression (2361); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation complaint received ad 13 apr 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges injury, pain, dislocations, pseudotumor, muscle and tissue destruction, metallosis, metal wear, loss of enjoyment of life and limitation of daily activities.Doi: (b)(6) 2009.Dor: (b)(6) 2021.Unk hip.

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 lot number: cd5kv1000 does not reflect a valid finished goods lot number.Therefore, a manufacturing records evaluation (mre) was not performed as no valid finished goods lot number was provided for this device.

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.Corrected: a1, d1, d2a, d2b, d4 (catalog), h6 (clinical and medical device problem code).

Event Description

Medical records were received and stated the following: after review of medical record, revision notes stated that a large fluid was encountered serous in nature, there is grayish tint to the tips of the abductor.There was corrosion at the trunnion and metal wear debris.There is significant amount of uncovering the cup and appeared osteolysis around the posterior superior cup.There was minimal corrosion at the back of the liner.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 (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 (b)(4) medical records ad (b)(6) 2023 (4).( (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.Doi: (b)(6) 2009.Dor: (b)(6) 2021.Right 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 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

Litigation alleges elevated metal ions, toxic heavy metals, pain, discomfort, bone loss, tissue death.It was also stated that there is a full thickness abductor tear of superior and posterior abductors.There is a grayish tint to the tips of the abductors but was fairly fibrous throughout.There was little tissue viable to repair and all was fibrotic.There is a significant amount of corrosion on the trunnion.Following plaintiff initial revision.Plaintiff suffered 3 dislocations on the following dates.(b)(6) 2022; (b)(6) 2022; (b)(6) 2022.All were reduced via closed reduction.Due to pain and repeated dislocation plaintiff was forced to undergo a re-revision on (b)(6) 2022.Plaintiff was also experiencing difficulties standing, sitting, walking, climbing stairs and performing adl, limited range of motion and fear of life.After review of the medical records revised the patient was revised due to failed right tha resulting to abductor tear, elevated metal ions, elevated crp, pseudotumor and right hip pain.Head and liner exchange to a polyethylene and ceramic head with ts.Operative note reported there was a large fluid collection.Fairly serous in nature, all tissue were hypertropic and very fibrous, had a full thickness abductor tear on the offer superior and posterior abductors.There is a grayish tint to the tips of the abductor.There was corrosion on the head and trunnion.Metal wear debris were removed.There was significant amount of uncovering of the cup.There was osteolysis around the cup.Minimal corrosion encountered in the liner.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of photo, x-ray and video evidence provided found insufficient evidence to confirm corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device (157002100/cd5kv1) product and lot numbers, and no non-conformances were identified.Device history review a manufacturing record evaluation was performed for the finished device (157002100/cd5kv1) product and lot numbers, and no non-conformances were identified.

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: a4, a5, a6, b5, b6, b7, h6 health effect - clinical code.H6: inflammation (e2326) is being utilized to capture bursitis.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.In addition to what was previously reported in the medical records active problem reported trochanteric bursitis, hematoma, depression and limited adl.Doi: (b)(6) 2009; dor: (b)(6) 2021; right hip first revision.

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: SUMMIT DUOFIX TAP SZ4 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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: 14315650
• MDR Text Key: 291218872
• Report Number: 1818910-2022-08348
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 1570-02-100
• Device Catalogue Number: 157002100
• Device Lot Number: CD5KV1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 03/01/2023; 03/21/2023; 04/14/2023; 06/23/2023; 08/24/2023; 10/02/2023
• Supplement Dates FDA Received: 03/20/2023; 03/21/2023; 04/28/2023; 06/25/2023; 09/15/2023; 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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: ARTICULEZE M HEAD 36MM -2; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT DUOFIX TAP SZ4 STD OFF; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White