MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 14D SML; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	550503
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/16/2018
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.(b)(4).
Event or Problem Description
The patient was revised due to hip pain.X-rays shows subsidence of the sleeve and stem.The doctor revised the femoral component.Cup and poly as well.Stem and sleeve loosening at bone to implant interface.Doi: (b)(6) 2013.Dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned devices was not able to confirm the reported event.No evidence was found indicating product error was a contributing factor.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ZT TRIAL SLEEVE 14D SML
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8156048
• Report Number: 1818910-2018-77918
• Device Sequence Number: 1987904
• Product Code: LPH
• UDI-Device Identifier: 10603295146292
• UDI-Public: 10603295146292
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2018

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: 550503
• Device Lot Number: B0912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/02/2019; 01/07/2019; 04/24/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/03/2019; 01/08/2019; 05/22/2019
• 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: 53 YR