MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	52-1463
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	05/18/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Litigation alleges the patient suffers from pain.Update rec'd 11/7/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from inflammation, discomfort, and large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.Update 1/23/2015 - the revision operative note indicated pain and pseudotumor.No labs were provided for the alleged high metal ions.Update 11/25/2015- pfs and medical records received.The medical records reported pseudotumor, subluxation, and osteolysis at tip of greater trochanter.Serum cobalt lab level of 70 (ref 0.9) dated (b)(6) 2010 within medical records.Update ad 4 may 2018: the receipt of ppf and medical records.In addition to what were previously alleged, ppf alleges pseudotumor, constrained liner, dislocation with closed reduction, loosening of the stem, metal wear, and metallosis.After review of medical records, no operative notes provided.Added s-rom sleeve due to loosening of stem.
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, 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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8281248
• Report Number: 1818910-2019-82479
• Device Sequence Number: 13973319
• Product Code: LPH
• UDI-Device Identifier: 10603295170617
• UDI-Public: 10603295170617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 03/31/2010
• Device Model Number: 52-1463
• Device Catalogue Number: 521463
• Device Lot Number: 1855905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 05/11/2020
• 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: 45 YR
• Patient Weight: 59