MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 20D-SML; HIP FEMORAL STEM/SLEEVE

Model Number	55-0533
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Joint Swelling (2356); Inadequate Osseointegration (2646)
Date of Event	11/18/2013
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
Litigation alleges the patient suffers from pain.Update jul 05, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges swelling, limping, improper foot alignment, tissue necrosis.After review of the medical records for mdr reportability, it was stated that the patient was revised to address aseptic loosening of the femoral component and failed metal/metal articulation.Revision note stated that the stem was found to be grossly loose, significant overgrowth of heterotopic bone and overgrowth of the trochanter.Added stem and sleeve due to the reported loosening.Part and lot information were provided.This complaint was updated on: jul 19, 2017.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges loosening of stem and elevated metal ions.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Corrected: h6 (device codes).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 will be filed as appropriate.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6754109
• Report Number: 1818910-2017-21974
• Device Sequence Number: 16176073
• Product Code: LPH
• UDI-Device Identifier: 10603295175339
• UDI-Public: 10603295175339
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2017

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: 03/01/2014
• Device Model Number: 55-0533
• Device Catalogue Number: 550533
• Device Lot Number: 2880632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 12/30/2018; 01/31/2020
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 01/08/2019; 02/10/2020
• 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: 76 YR
• Patient Weight: 84