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	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	08/13/2021
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
Revision total hip replacement for osteolysis and loosening.Revision of femoral prosthesis and acetabular liner.Original surgeon (b)(6) private hospital surgery date (b)(6) 1999.Doi: (b)(6) 1999; dor: (b)(6) 2021; unknown side.
Event or Problem Description
Additional information received indicated that there was lysis around the proximal section of the femoral component.It was difficult to remove and it felt like the femoral component was "widescreen wipering" in the femur.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : product code 52-3422, work order (b)(4) was manufactured on 16-march-1999.(b)(4) parts were manufactured per specification and all raw materials met specification.There was scrap associated with this lot.One (1) part scrapped at the inspect process step for dent / scratch in proximal taper.There is no correlation between this and the failure mode of the complaint.There is no reprocessing associated with this lot.There was no non-conformance associated with this lot.

• 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: 12407418
• Report Number: 1818910-2021-19091
• Device Sequence Number: 5260930
• Product Code: LWJ
• UDI-Device Identifier: 10603295171058
• UDI-Public: 10603295171058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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 Expiration Date: 03/22/2004
• Device Model Number: 52-3422
• Device Catalogue Number: 523422
• Device Lot Number: 625515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 10/06/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/15/2021; 10/06/2021
• 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; CANCELLOUS BONE SCREW 6.5X25MM; CANCELLOUS BONE SCREW 6.5X40MM; DURALOC SECTOR POLISHED 56 HA; ENDURON 10D 56 OR 68ODX28ID; S-ROM*HEAD FEMRL ZIRCONIA 28+6; S-ROM*SLEEVE PRX ZT HA 22D-SML; SROM*STM ST,36+8L NK,22X17X165; APEX HOLE ELIM POSITIVE STOP; CANCELLOUS BONE SCREW 6.5X25MM; CANCELLOUS BONE SCREW 6.5X40MM; DURALOC SECTOR POLISHED 56 HA; ENDURON 10D 56 OR 68ODX28ID; S-ROM*HEAD FEMRL ZIRCONIA 28+6; S-ROM*SLEEVE PRX ZT HA 22D-SML; SROM*STM ST,36+8L NK,22X17X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR