MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0525
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/18/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter 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
Medical record received.After review of medical record, patient was revised to address failed left total hip arthroplasty.Patient had left hip pain.Revision notes stated.Schlerotic bone in the trochanteric bed and the proximal sleeve was removed as it was not ingrown and was grossly loose.Doi: (b)(6) 2005; dor: (b)(6) 2012 (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2012-12223 will be kept for investigation purposes.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The device was reported in error due to duplication.Mfr# 1818910-2020-09937 is being retracted and mfr# 1818910-2012-12223 will be kept for investigation purposes.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9912442
• Report Number: 1818910-2020-09937
• Device Sequence Number: 3354891
• Product Code: LPH
• UDI-Device Identifier: 10603295175308
• UDI-Public: 10603295175308
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2020

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: 55-0525
• Device Catalogue Number: 550525
• Device Lot Number: 1177476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/11/2020; 05/14/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/11/2020; 05/14/2020
• 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: PINNACLE MTL INS NEUT36IDX58OD; S-ROM M HEAD 36MM +3; SROM*STM ST,36+8L NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 82