MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,22X17X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3422
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 total hip to address hip dislocation and polyethylene liner wear.Date of implantation: (b)(6) 2002.Date of revision: (b)(6) 2021.(right hip).Treatment: revision of acetabular liner and femoral head.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13013862
• Report Number: 1818910-2021-25780
• Device Sequence Number: 5441411
• Product Code: LWJ
• UDI-Device Identifier: 10603295171058
• UDI-Public: 10603295171058
• 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: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 52-3422
• Device Catalogue Number: 523422
• Device Lot Number: 573034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/1999
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; PINN MAR NEUT 28IDX60OD; PINNACLE 100 ACET CUP 60MM; S-ROM*HEAD FEMORAL COCR 28+6; S-ROM*SLEEVE PRX ZTT, 22B-LRG; SROM*STM ST,36+8L NK,22X17X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown