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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problem 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.(b)(4).

Event Description

"the literature article entitled, ""early failure of hylamer acetabular inserts due to eccentric wear"" written by michael j.Chmell, md, robert poss, md, william h.Thomas, md, and clement b.Sledge, md published by the journal of arthroplasty vol.11 no.3 1996 was reviewed.The article's purpose was to report on cases of early failures necessitating liner revision due to eccentric wear of the bearing surface.Data was compiled from 5 cases that received implants between january 1991 and december 1992.The article reports all patients received duraloc porous-coated cups with hylamer poly liners and were paired with depuy and non-depuy femoral components.It is noted that all but 1 cups are mispositioned.All revisions had notations of confirmed poly debris present and synovitis.The articles focuses on the liner wear requiring revision but makes mention of one uncemented stem that was revised for loosening.This finding is captured in its own complaint as generalized adverse events and the 5 cases are captured individually in linked complaints for liner wear requiring revision." this complaint captures case 4 a (b)(6) female that experienced implant failure 34 months post implantation that required revision of liner due to wear.Cup inclination 50 degrees.

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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: 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 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 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: 9460246
• MDR Text Key: 185502629
• Report Number: 1818910-2019-122862
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR