MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ASPHERE; S-ROM Femoral Heads (11/13) : Hip Metal Femoral Heads

Catalog Number	136533100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2010, patient received a primary left total hip replacement to address avascular necrosis of the left femoral head, and degenerative joint disease of the left hip.Implants placed were depuy 52 mm diameter pinnacle 100 acetabular cup with an apex hole eliminator, 36 mm inner diameter by 52 mm outer diameter neutral pinnacle metal acetabular insert, and a 36 mm +6 asphere metal-on-metal femoral head, an s-rom 18 x 13 femoral stem with 36 + 8 lateral off set neck, 18d small ztt sleeve.There were no complications reported.(b)(6) 2023, the patient allegedly developed sudden onset of severe left hip and groin pain accompanied by a pulling sensation.Although some medical records reference a possible slip and fall, the patient does not recall any fall and reports that the symptoms began spontaneously.Due to worsening pain, the patient sought medical evaluation in (b)(6) 2023.Diagnostic imaging reportedly revealed osteolysis, a left lesser trochanter fracture, and significant osteolytic disease involving the proximal femur associated with a large-head metal-on-metal hip articulation.Subsequent metal-on-metal testing and metal ion studies reportedly identified metallosis, extensive osteolysis, and pseudotumor formation associated with the implanted device.(b)(6) 2023, the patient underwent a left hip aspiration (synovasure) procedure due to a history of left tha with elevated crp and chromium levels.On (b)(6) 2023, a left hip mri (mars protocol) demonstrated a multilobulated fluid collection surrounding the left hip, tiny loose bodies at the lesser and greater trochanters, suspected pseudotumor formation, osteolytic/erosive changes, and a prior fracture of the left lesser trochanter.(b)(6) 2023 patient had a left hip mri using mars protocol to assess soft tissues.Results: non-specific multilobulated postoperative fluid collection located anterior and posterior to the left hip joint, as well as along the posterior and mediai aspect of the intertrochanteric and subtrochanteric region with tiny loose bodies noted at the level of the lesser trochanter and greater trochanter.Suspect pseudotumor with loose bodies within.Infection cannot be excluded.Signal abnormality of the lesser trochanter and greater trochanter at the sites of lucency seen on plain x-ray film.Suspect erosions and/or osteolysis.There is also a prior fracture of the left lesser trochanter.On (b)(6) 2023, the patient underwent left hip revision surgery.Intraoperative findings documented widespread osteolysis, pseudotumor formation, and metallosis.The lesser trochanter fracture was noted radiographically and was determined to be a pathological fracture secondary to severe, long-standing osteolysis and pseudotumor formation.No specific surgical treatment of the fracture was required.During the revision procedure, he was noted to have significant osteolytic disease about the posterior aspect of the femur with ectatic changes about the lesser trochanter.Devitalized bone was excised with a rongeur.The hip was dislocated and the head was removed with an offset bone tamp.There was slight varnishing around the taper; however, overall it appeared normal.The metaphyseal sleeve was felt to be ingrown and the stem well fixed.Attention was then turned to the acetabular liner.The femur was translocated anteriorly.Retractors were placed about the acetabulum.An offset bone tamp was used to remove the existing liner.The patient alleges that, despite undergoing revision surgery and subsequent physical therapy, he continues to experience permanent functional limitations affecting mobility and activities of daily living.The patient further alleges that he was unable to return to work, was forced to take early retirement, and has suffered emotional distress, loss of self-esteem, loss of independence, and loss of professional identity.Doi: (b)(6) 2010, dor: (b)(6) 2023.Affected side: left hip,.
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: ASPHERE
• Common Device Name: S-ROM Femoral Heads (11/13) : Hip Metal Femoral Heads
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50473055
• Report Number: 1818910-2026-14661
• Device Sequence Number: 10136060
• Product Code: JDI
• UDI-Device Identifier: 10603295033516
• UDI-Public: (01)10603295033516(17)140722(10)2971218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 07/22/2014
• Device Catalogue Number: 136533100
• Device Lot Number: 2971218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male