MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103540000

Device Problems Fracture (1260); Off-Label Use (1494); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 05/26/2020

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

It was reported that a wright medical head was used with our bipolar head, causing suspicion poly wear and instability.Doi: unknown; dor: (b)(6) 2020; affected side: 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device finds no obvious poly material wear or unusual wear pattern.It is noted that the head is competitor manufactured.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.

• Brand Name: SELF CENT HIP 40X28 RUST
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10130855
• MDR Text Key: 194457060
• Report Number: 1818910-2020-13406
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103540000
• Device Lot Number: 578696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HIP FEMORAL HEAD (COMPETITOR); UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Patient Outcome(s): Required Intervention