MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*SLEEVE PRX ZTT, 20F-XXL; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0540
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	03/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: lawyer.
Event or Problem Description
New ecm record created in order to update legacy complaint (b)(4).The patient was revised because of infection and cup loosening.Update ad 21 may 2019.(b)(4) is a reopen of (b)(4) due to receipt of pinnacle claim submission form, implant and medical records.After review of medical records, the patient was revised to address septic loosening.Operative findings include inflammatory tissues, loose cup as well as stem, a large fluid collection within the joint and necrotic tissue.Revision implants are from depuy.Antibiotic-laden cement was used on the acetabulum and femoral canal.These were removed 3 months after as planned with no complications.Doi: (b)(6) 2011 - dor: (b)(6) 2014, (right 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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8688131
• Report Number: 1818910-2019-95732
• Device Sequence Number: 3030503
• Product Code: LPH
• UDI-Device Identifier: 10603295175377
• UDI-Public: 10603295175377
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2014

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: 04/01/2016
• Device Model Number: 55-0540
• Device Catalogue Number: 550540
• Device Lot Number: 3293992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 10/29/2020
• 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: 58 YR
• Patient Weight: 81