MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +6 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-18-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2021

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 as revision i and d for infection.Patient has our stem and a competitive companies cup.Doi: unknown, dor: (b)(6) 2021, affected side: left 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.H10 additional narrative: added: d10 concomitant med products.

• Brand Name: SROM 28MM +6 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11237743
• MDR Text Key: 228924527
• Report Number: 1818910-2021-01903
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295033165
• UDI-Public: 10603295033165
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-18-500
• Device Catalogue Number: 136518500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CUP.; COMPETITOR LINER.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR