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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Disorder (2373); No Code Available (3191)
Date of Event	10/10/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision total hip replacement; dr (b)(6), (b)(6) hospital, (b)(6) 2020: revision due to dislocation and instability.Case will likely have previous reports as previous revision ((b)(4)) has occurred for instability neck of srom stem notched due to impingement with acetabular component.Evidence of macroscopic staining from metal wear impingement of femoral stem with acetabular component.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10754582
• Report Number: 1818910-2020-23515
• Device Sequence Number: 3318472
• Product Code: JDI
• UDI-Device Identifier: 10603295170853
• UDI-Public: 10603295170853
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 52-3191
• Device Catalogue Number: 523191
• Device Lot Number: 1047985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN LNR CON +4 NEUT 28IDX50OD; S-ROM*HEAD FEMORAL COCR 28+0; S-ROM*SLEEVE PRX ZT HA 14B-SML; S-ROM*STM STD,36NK,14X09X130; PINN LNR CON +4 NEUT 28IDX50OD; S-ROM*HEAD FEMORAL COCR 28+0; S-ROM*SLEEVE PRX ZT HA 14B-SML; S-ROM*STM STD,36NK,14X09X130
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR