MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523420
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	03/20/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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
Litigation alleges that the patient suffers from pain, discomfort, inflammation, popping/snapping, difficulty ambulating, and elevated metal ion levels.Update: 7/3/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records indicate that the patient was revised on the left side because of metallosis, vertical cup, and slight corrosion.Records are available for further review.Update ad 30 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets and implant records.In addition to what were previously alleged, ppf alleges pseudotumor, metallosis and metal wear.Added law firm, lawyer, expiry date of the head, patient harm and pec.Doi: (b)(6) 2004 - dor: none reported (right hip) please see (b)(4) for the 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.
Event or Problem Description
After review of medical records patient was revised due to failed right hip arthroplasty, continued to have swelling and pain.Operative notes indicated fibrinous tissue with a present anterior to the abductors to the fascia.There was significant trunionosis and stem had slight retroversion.The previous stem was then systematically and carefully removed by using a taper breaker, a high-speed bur and a extraction device.There was significant bone between the shoulder of the implant in the greater trochanter, this was removed with care taken to maintain continuity of the trochanter.There was wear on the backside of the liner.Revision due to metallosis and hypersensitivity.It is reasonable to conclude the metallosis and hypersensitivity is a result of the interaction between the articulating surfaces and femoral head - stem trunnion micromotion and therefore the metal femoral head, metal acetabular liner, and femoral stem have been reported for contributing to the serious injuries.The femoral sleeve/acetabular cup does not articulate with another metal surface and it would be reasonable to assume it is not involved in the reported metallosis and hypersensitivity.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18623283
• Report Number: 1818910-2024-02180
• Device Sequence Number: 7576360
• Product Code: MRA
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 07/27/2009
• Device Catalogue Number: 523420
• Device Lot Number: 1197963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2004
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 20F-SML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 113 KG