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

Catalog Number	550523
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event	06/01/2015
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
Ppf alleges infection, loosening of stem and elevated metal ions.Doi: (b)(6) 2011, dor: (b)(6) 2015, (right hip).
Additional Manufacturer Narrative
(b)(4).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.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 IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8568539
• Report Number: 1818910-2019-92094
• Device Sequence Number: 2192129
• Product Code: LPH
• UDI-Device Identifier: 10603295175285
• UDI-Public: 10603295175285
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2014

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 Expiration Date: 06/30/2016
• Device Catalogue Number: 550523
• Device Lot Number: 3329742
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: 50 YR
• Patient Weight: 117