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

Catalog Number	550526
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Emotional Changes (1831); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Anxiety (2328); Distress (2329); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.E3 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 complaint received: the patient suffered personal and economic injuries as a result of the implantation with the asr hip implant.Severe and debilitating pain and weakness; significant inhibitions of his ability to walk or move; metallosis, elevated blood levels of chromium and cobalt; anxiety, fear, mental anguish and other emotional and physical damages.Affected site: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.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 there is no evidence suggesting manufacturing or material error as a potential cause for the incident involving the asr platform.Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: d10 (concomitant), e1 (facility name).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d1, d2a, d3, d4 (lot, expiration date, catalog), g4 pma/ 510(k), h4.Corrected: d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.
Additional Manufacturer Narrative
Mrn 1818910-2025-00645 is being retracted since it was found to be a duplicate of 1818910-2016-13716.Mrn 1818910-2016-13716 will be kept for investigation purposes.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21136864
• Report Number: 1818910-2025-00645
• Device Sequence Number: 15372785
• Product Code: LPH
• UDI-Device Identifier: 10603295175315
• UDI-Public: (01)10603295175315(17)121008(10)2478030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 10/08/2012
• Device Catalogue Number: 550526
• Device Lot Number: 2478030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 02/11/2025; 02/21/2025; 03/21/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/17/2025; 02/18/2025; 02/24/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2007
• 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: UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNKNOWN HIP FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male