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); Naturally Worn (2988)

Patient Problems Ossification (1428); Pain (1994); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 08/05/2012

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.(b)(4).

Event Description

The literature article entitled, "cementless modular total hip arthroplasty in patients younger than fifty with femoral head osteonecrosis: minimum fifteen-year follow-up" written by sang-min kim md, seung-jae lim md, young-wan moon md, yang-tae kim md, kyung-rae ko md, and youn-soo park md published by the journal of arthroplasty 28 (2013) 504¿509 accepted by publisher 5 august 2012 was reviewed.The article's purpose: "the purpose of this study was to report the clinical and radiographic results of cementless primary tha using a modular stem in a series of patients younger than fifty years with osteonecrosis of the femoral head who were followed for a minimum of fifteen years." the data was compiled from 64 hips (55 patients - 40 male and 15 female with average age of 40.2 years) with average follow up 15.8 years received implants from december 1994 to september 1996.Depuy products were utilized: srom femoral stem, cementless arthropore i or ii cup with poly liner in 60 hips and the remaining 4 hips were non-depuy cups.Bearing surfaces were cop (45 hips) and mop (19 hips).The article reports upon generalized results but also identifies 4 individual patients with adverse events that are capture on linked complaints.The article does not specify if patients received interventions based upon radiographic detections.The article reports "no hips showed femoral osteolysis without gross radiographic evidence of polyethylene wear and radiographic evidence of metallic debris.Loosening of femoral components was not seen in any of the cases in this series.This complaint captures the generalized adverse events without patient identifiers: mild thigh pain without restriction to patient activity (8), radiographic detection of stress shielding in femur (50), radiographic detection of ectopic ossification (16), radiolucency at bone component interface (37), femoral osteolytic lesions (23), acetabular revisions (14 total of which 1 is captured on an individual identified patient in a linked complaint) due recurrent dislocations and note of poly wear as a result and treated with isolated liner change and cup retention (5) and treated with liner change and cup explanation (9).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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 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.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).Additional information: h6 patient code (3189) used to capture medical device removal.

• 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: 9248243
• MDR Text Key: 177253190
• Report Number: 1818910-2019-108996
• 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: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 12/23/2019
• Supplement Dates FDA Received: 11/01/2019; 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention