MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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

Literature article entitled: "five- to ten-year outcomes for modular metal-on-metal total hip arthroplasty" three hips were revised to address instability with recurrent dislocations.The accounts provided no additional information, such as which products were revised.Three hips were revised for infection, with all three requiring two-stage procedures involving explantation and antibiotic spacer placement, followed by a second procedure to re-implant permanent devices once infection had cleared.The dates when the infections occurred with respect to the original dates of implantation were not provided for any of these three hips.One hip was revised to address a periprosthetic bone fracture, resulting from a ground fall, involving an unspecified bone.The fracture was reportedly treated with an orif and the original implants, all well-fixed, were preserved (unrevised).Finally, two hips were revised to address pain of indeterminate cause.One of these patients did have elevated serum metal ions (cobalt = 15 ¿g/ml and chromium = 63 ¿g/ml), while the other patient had normal levels.The patient with normal metal ion levels did have some histological evidence of lymphoplasmacytic perivasculitis, but no evidence of lymphocyte-dominated immune response (altr) was observed according histological criteria.Both patients had pristine soft tissues, without sign of infection, metal wear, or component failure at the time of revision.The components were all well fixed but were still revised to ceramic-on-uhmwpe in both cases.Patients improved significantly following conversion of the articulating bearing to a ceramic on highly cross-linked polyethylene.

Manufacturer Narrative

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8671756
• MDR Text Key: 147092329
• Report Number: 1818910-2019-95307
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention