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

Catalog Number	550534
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	02/15/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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, discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update 9/30/2015 - pfs and medical records received.After review of the medical records for mdr reportability, a correct dor was provided.The patient was revised on (b)(6) 2013 for infection.All implants were removed and spacers were placed.The patient was reimplanted on (b)(6) 2013 with competitor products.The (b)(6) 2013 revision operative note indicated loosening, but didn't indicate which products were loose.Lab results within the pfs indicated the metal ion levels were less than 7ppb.At this time infection isn't alleged per the litigation.All other products are being added to the complaint, but put in as mdr nos.Part / lot is being updated for the head / liner.Update ad 13 sep 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges loosening of cup and stem.After re-review of medical records attached in etq, revision notes did not mention any loosening.Doi: (b)(6) 2007.Dor: (b)(6) 2013, (left hip).
Additional Manufacturer Narrative
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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9185445
• Report Number: 1818910-2019-109619
• Device Sequence Number: 16846941
• Product Code: LPH
• UDI-Device Identifier: 10603295175346
• UDI-Public: 10603295175346
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2014

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2011
• Device Catalogue Number: 550534
• Device Lot Number: 2263883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: 60 YR
• Patient Weight: 95