MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30 NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3292
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.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
Pfs and medical records received.Pfs alleges pain, discomfort and metallosis.After review of medical records patient was revised to address failed left total hip arthroplasty.Revision notes reported mild metallosis with tan staining of the right hip joint tissues.Fibrinous exudative tissue at the base of the greater trochanter and calcar with mild trunnionosis with black staining at the morse taper junction of the asr head and stem.Clinic visits reported of crunching, popping and grinding.Doi: (b)(6) 2007 - dor: (b)(6) 2019 (left hip).
Additional 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.

• 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: 10508848
• Report Number: 1818910-2020-19672
• Device Sequence Number: 3032992
• Product Code: JDI
• UDI-Device Identifier: 10603295170976
• UDI-Public: 10603295170976
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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 Expiration Date: 04/30/2012
• Device Model Number: 52-3292
• Device Catalogue Number: 523292
• Device Lot Number: 2372706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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: ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; S-ROM*SLEEVE PRX ZTT, 16D-SML; S-ROM*STM STD,30 NK,16X11X150; ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; S-ROM*SLEEVE PRX ZTT, 16D-SML; S-ROM*STM STD,30 NK,16X11X150
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 95