MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3193
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Synovitis (2094); No Code Available (3191)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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
Pinnacle medical record received.After review of medical record, patient was revised to address pain and synovitis.Revision notes stated that a bulging thickened hip capsule was noted.A 10cc of dark red particulate fluid was removed from the joint and dark red brown effusion was evacuated.The head and liner were removed.There was moderate amount of trunnionosis and corrosion of the femoral trunnion.Operative findings noted metallosis with mark effusion, large pseudotumor, and osteolysis.Blood cobalt levels were increasing but less than 7 ppb.Clinic visits noted erosions of proximal femur.Doi: (b)(6) 2006 - dor: (b)(6) 2020 (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.H10 additional narrative: added: d11.Corrected: e1, e2, e3.E3 initial reporter occupation: lawyer.A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.

• 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: 10676893
• Report Number: 1818910-2020-22255
• Device Sequence Number: 2942612
• Product Code: JDI
• UDI-Device Identifier: 10603295170877
• UDI-Public: 10603295170877
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Model Number: 52-3193
• Device Catalogue Number: 523193
• Device Lot Number: 2138884
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; S-ROM M HEAD 36MM +6; S-ROM*SLEEVE PRX ZTT, 18F-SML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR