MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 18F-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Date of Event	12/16/2011
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Reason for original complaint: litigation alleges that patient has experienced severe pain and toxic levels of cobalt and chromium in her blood.Records indicate that the patient was revised because of alval, metallosis, elevated ion levels, noise, and the stem loose in the sleeve.In addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.Added hospital, law firm, sleeve was added due to loosening of the stem.Doi: (b)(6) 2009.Dor: (b)(6) 2010, (right hip) initial.
Additional Manufacturer Narrative
Product complaint (b)(4).1818910-2019-107188 is being retracted since this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Event or Problem Description
Upon review of the medical records from the (b)(6) 2010 revision, the surgeon states "the femoral sleeve was secure and the stem was secure within the sleeve but upon simple removal attempts on the femur, it was noted that the femoral stem was fairly loose and easily removed" therefore, the sleeve is not reportable at this time as no patient harm occurred from this product.
Additional 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 will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9144867
• Report Number: 1818910-2019-107188
• Device Sequence Number: 11472578
• Product Code: LPH
• UDI-Device Identifier: 10603295175308
• UDI-Public: 10603295175308
• 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: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2012

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: 550525
• Device Lot Number: 2536706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 12/10/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/25/2019; 01/07/2020
• 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: 64 YR
• Patient Weight: 64