MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 P.F.C.* 28MM HEAD +0MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS

Model Number 85-3831

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/19/2021

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.

Event Description

The patient was revised to address hip dislocation.New head and liner.Doi: unknown.Dor: (b)(6) 2021.Affected side: 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 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 : a device history record (mre) review, was not possible because the required lot code was not provided.

• Type of Device: PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11765315
• MDR Text Key: 248764697
• Report Number: 1818910-2021-09442
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295207597
• UDI-Public: 10603295207597
• 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: 04/19/2021

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: 85-3831
• Device Catalogue Number: 853831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUR MAR NEUT LINER 28IDX54OD; DURALOC DYNAMIC LOCK RING 54MM; P.F.C.* 28MM HEAD +0MM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 59