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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/27/2021

Event Type  Injury  

Event Description

The patient was revised due to pain.Doi: unknown.Dor: (b)(6) 2021, affected side: left hip.

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.

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 : for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12819618
• MDR Text Key: 280812726
• Report Number: 1818910-2021-25153
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295207597
• UDI-Public: 10603295207597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K893872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 85-3831
• Device Catalogue Number: 853831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P.F.C.* 28MM HEAD +0MM; P.F.C.*LINR 48-52/10 DEG-28MM; PFC CUP; PFC SCREW; PFC SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 62 KG