MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SROM*STMLG36+21CR8L 18X13X215L; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563018L
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised to address pain and loosening of the stem and sleeve at the bone to implant interface in the left hip 23 years following thr.Surgeon removed locking pins, cup, liner, dome screws, sleeve, stem and head.The ztt cup remained implanted.The surgeon placed a new poly dial liner locking pins.Doi: (b)(6) 1996.Dor: (b)(6) 2019, left hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8884517
• Report Number: 1818910-2019-100768
• Device Sequence Number: 11362056
• Product Code: KXA
• UDI-Device Identifier: 10603295177302
• UDI-Public: 10603295177302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 563018L
• Device Lot Number: SE100107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/02/2019
• 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: S-ROM*HEAD FEMORAL COCR 28+12; S-ROM*INSERT L32,10DEG,28MM 3M; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,6.5MM DIA,20MM LG; S-ROM*SCREW,6.5MM DIA,30MM LG; S-ROM*HEAD FEMORAL COCR 28+12; S-ROM*INSERT L32,10DEG,28MM 3M; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,6.5MM DIA,20MM LG; S-ROM*SCREW,6.5MM DIA,30MM LG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 93