MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 S-ROM*SLEEVE PRX ZTT, 18B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	52-1483
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Pcf and medical records received.After review of medical records, patient was revised to address failed left total hip replacement, aseptic loosening of left total hip replacement, and failed metal-on-metal total hip arthroplasty.Patient was with a painful left total hip, was found to have aseptic loosening of her left femoral stem, and was also found to have a metal-on-metal total hip arthroplasty.Operative notes stated that the short external rotators were identified and tagged for later repair.The femoral stem was grossly loose and was able to move it by hand.The s-rom ztt proximal sleeve and stem were well connected.The hoop extractor was used and following removal of lateral bone with a high-speed bur, the stem was removed without any bone loss.It was grossly loose.Reverse curettes were used to clean the pseudomembrane out the femoral canal.Scar and pseudocapsule was debulked.The leg lengths with disarticulation were recreated.The patient was short prior to surgery from the loose subsided stem.Doi: (b)(6) 2011.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 SLEEVE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10056620
• Report Number: 1818910-2020-12096
• Device Sequence Number: 14292241
• Product Code: LPH
• UDI-Device Identifier: 10603295170631
• UDI-Public: 10603295170631
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 05/31/2016
• Device Model Number: 52-1483
• Device Catalogue Number: 521483
• Device Lot Number: 3308201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR