MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18D-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550524
Medical Device Problem Codes	Degraded (1153); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
Date of Event	04/16/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient had a failed acetabular component on metal-on-metal total hip with evidence of trunnion corrosion and no evidence of infection.During the operation, there was no evidence of pus and metallosis but there was some mild staining metallic-looking in the inferior aspect of the acetabulum.There was some mild staining behind the liner but very minimal.The stem was grossly loose, had rotated into retroversion and was grown over with bone.The head had some corrosion of the taper.The sleeve was then cut using sharp dissection because it was scarred down.Doi: on (b)(6) , 2009, dor: on (b)(6) 2014, left hip.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19632333
• Report Number: 1818910-2024-14067
• Device Sequence Number: 17926480
• Product Code: LPH
• UDI-Device Identifier: 10603295175292
• UDI-Public: (01)10603295175292(10)2777327(17)131105
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 11/05/2013
• Device Catalogue Number: 550524
• Device Lot Number: 2777327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/13 S-ROM 40MM M SPEC+3.; PINNACLE MTL INS NEUT40IDX58OD.; PINNACLE SECTOR II CUP 58MM.; SROM STM STD 36+12L 13X18.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male