MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 S-ROM*SLEEVE PRX ZTT, 14B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550502
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/26/2018
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
Implants were loosened.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.Device history lot 4334728 device history review no anomalies 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 US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7978666
• Report Number: 1818910-2018-72870
• Device Sequence Number: 1368506
• Product Code: LPH
• UDI-Device Identifier: 10603295175186
• UDI-Public: 10603295175186
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: 550502
• Device Lot Number: 4334728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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