MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 16F-SML; HIP FEMORAL STEM/SLEEVE

Catalog Number	550515
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Information (3190)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Pfs and medical records received.Pfs alleges constant pain.After review of medical records for mdr reportability, it was reported that the patient was revised to address loosening.Revision notes reported the srom sleeve had no ingrowth and the femoral stem therefore was moving within in bone, causing the patient pain.It was also reported that the patient was found to be slightly short on the right side, consistent with subsidence and loosening.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
In addition to what was previously alleged, ppf alleges loosening of cup and stem.Updated associated contacts, added revision hospital.Added cup (b)(4).
Additional Manufacturer Narrative
(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 will be filed as appropriate.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6968137
• Report Number: 1818910-2017-27241
• Device Sequence Number: 19157748
• Product Code: LPH
• UDI-Device Identifier: 10603295175254
• UDI-Public: 10603295175254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2017

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: 05/31/2020
• Device Catalogue Number: 550515
• Device Lot Number: 8131039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 08/03/2018; 07/23/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 08/06/2018; 08/17/2018
• 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
• Patient Age: 54 YR
• Patient Weight: 109