MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3191

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pcf and medical records received.After review of medical records, the patient was revised due to metal-on-metal left total hip replacement with ion production secondary pain.Operative notes reported that the liner and head were slightly discolored.Doi: (b)(6) 2004.Dor: (b)(6) 2019.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, 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: per (b)(4), review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11047954
• MDR Text Key: 222767113
• Report Number: 1818910-2020-27360
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295170853
• UDI-Public: 10603295170853
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 52-3191
• Device Catalogue Number: 523191
• Device Lot Number: 1024236
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE MTL INS NEUT28IDX50OD; S-ROM*STM STD,36NK,14X09X130; SROM 28MM +0 M HEAD; PINNACLE MTL INS NEUT28IDX50OD; S-ROM*STM STD,36NK,14X09X130; SROM 28MM +0 M HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR