MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 12B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 550570

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Lab levels provided for metal ion levels indicated the metal ion levels are above 7ppb.The stem has already been reported on (b)(4).A poly liner is implanted and no revision date has been provided.Update ad 8 aug 2018: (b)(4) was re-opened under (b)(4) due to receipt of ppf, sticker sheets and implant records.In addition to what was previously alleged, ppf alleges dislocation, loose cup and stem, and bone fracture.Added cup, screw, liner and sleeve to the complaint.The stem has been reported on (b)(4).Added law firm and lawyer.Updated patient initials.At this time it¿s unknown where the fracture occurred.If/when more information is received, the pc will be updated as needed.Doi: (b)(6) 2005 (cup,screw,sleeve); doi: (b)(6) 2009 (head and liner); dor: none reported; left hip.

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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9267505
• MDR Text Key: 184737026
• Report Number: 1818910-2019-113643
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295175506
• UDI-Public: 10603295175506
• Combination Product (y/n): N
• PMA/PMN Number: K934412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 550570
• Device Lot Number: 1029860
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 74