MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 18B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	521483
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	07/24/2019
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 primary surgery was performed via tha (date of primary surgery was unknown).It was reported that the revision surgery was performed on (b)(6) 2019 by replacing the insert (p/n: 121887354), the cup (manufactured by kyocera, p/n: 121782054), the stem (p/n: 900535210) with the sleeve (p/n: 521483), the head (p/n: 962710000) due to implants alignment error, pain caused by loosen.The surgery was completed without problem and it was unknown whether there was a surgical delay or not.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8889810
• Report Number: 1818910-2019-100993
• Device Sequence Number: 1829102
• Product Code: LPH
• UDI-Device Identifier: 10603295170631
• UDI-Public: 10603295170631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 521483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: 9/10 ULTAMET 36MM HEADS -3; PINNACLE MTL INS NEUT36IDX54OD; 9/10 ULTAMET 36MM HEADS -3; PINNACLE MTL INS NEUT36IDX54OD
• Outcome Attributed to Adverse Event: Required Intervention