MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 28MM +0 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-16-500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/21/2021

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 the patient had dislocated her constrained liner multiple times again.Cup, screw.Liner and head were removed and a zb cup and dual mobility was placed with a 28+12 srom head inserter into competitor dual mobility poly head.Constrained liner was still intact and ring was still in correct location.Don't have records for the cup or screw that was removed.It was a 50 pinnacle cup and what looked to be a 35mm screw.Doi: (b)(6) 2020 dor: (b)(6) 2021 right hip.

Manufacturer 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, 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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM 28MM +0 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11762822
• MDR Text Key: 248636529
• Report Number: 1818910-2021-09434
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295033141
• UDI-Public: 10603295033141
• Combination Product (y/n): N
• PMA/PMN Number: K893872
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-16-500
• Device Catalogue Number: 136516500
• Device Lot Number: 8341059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention