MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 11/16/2015

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.(b)(4).

Event Description

The literature article entitled, "cementless revision total hip arthroplasty with ceramic articulation" written by jong-hyuck yang, md, seong-jo yang, md, joon-soon kang, md, kyoung-ho moon, md published by hip and pelvis 27(4): 223-231, 2015 with final publisher acceptance november 16, 2015 was reviewed.The article's purpose was to evaluate the clinical and radiological outcomes of revision tha using the third and fourth generation coc articulations in younger patients for intermediate-term durations.Data was compiled from 103 patients who received revision thas between january 2000 to aprils 2012 with mean age of 51.6 years.Depuy products utilized (all patients): duraloc cups until june of 2007 and the pinnacle cups with ceramic liners.Ceramic femoral head with aml stems and solution stems.Original implants are not known or identified.Adverse events: squeaking noise (no interventions or revision), limp in walking and require walking aids, limb length discrepancy (0 to 2 cm) without impact to function and no interventions, dislocation treated by closed reduction under general anesthesia and one treated with re-revision due to recurrent dislocations with change of cup (not identified) and head, joint infections treated with re-revision (pinnacle cup identified) with changing of cup and femoral head, cup re-revision due to loosening (pinnacle cup identified).The article does not provide adequate information to determine accurate quantities.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: added: h6 (device).Corrected: h6.Product complaint # : (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null device history batch : null device history review : null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9249514
• MDR Text Key: 177589711
• Report Number: 1818910-2019-112767
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention