MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Date of Event	08/07/2020
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
Clinical notification received for revision of right hip to address metallosis date of implantation: (b)(6) 2002, date of revision: (b)(6) 2020, (right hip).Treatment: revision of head and liner products.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.X-ray images have been reviewed and the only allegation that could be confirmed was the cup being dispositioned.The root cause could not be confirmed.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.H10 additional narrative:.
Event or Problem Description
On (b)(6) 2002, the patient received a right pinnacle/srom mom to treat pain and dysfunction secondary to osteoarthritis.Intraoperatively, the surgeon notes there was femoral head arthrosis, mild synovitis, and significant calcification of the labrum.The patient received a pinnacle cup, metal ultamet liner, cocr head, ztt sleeve, and srom stem.The procedure was completed without complications.Clinic note dated (b)(6) 2020, indicated that the patient presented with right hip pain.Radiology reports revealed that the cup was vertical.The surgeon suspected metallosis and scheduled the patient for a revision of the right hip.On (b)(6) 2020, the patient received a total revision of the right hip to treat pain secondary to suspected armd.Upon entering the joint, the surgeon identified and excised scar tissue and a pseudocyst.The cup was well-fixed but vertical, and revised.The stem and sleeve were well-fixed but revised.There was no wear identified on the revised metal liner.The head had some trunnionosis, but no evidence of wear, and was revised.The surgeon noted that there was no metallosis in the joint and no pseudotumor present.The patient was revised with depuy products.The procedure was completed without complications.Doi: (b)(6) 2020.Dor: (b)(6) 2020.Right hip.

• 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: 10600883
• Report Number: 1818910-2020-21109
• Device Sequence Number: 14357654
• Product Code: JDI
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Device Lot Number: 1005252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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 MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; S-ROM M HEAD 36MM +0; SROM SLEEVE; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP ACETABULAR CUP; PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; S-ROM M HEAD 36MM +0; SROM SLEEVE; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 69