MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4)."failure of metal-on-metal total hip arthroplasty mimicking hip infection¿ by mark m.Mikhael et al.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿failure of metal-on-metal total hip arthroplasty mimicking hip infection¿ by mark m.Mikhael et al reports two patients with failure of metal-on-metal implants who presented with signs that mimicked a deep-seated hip infection.Although the two cases were similar in terms of the clinical presentation, each ultimately represented a different pathological condition and etiology.A (b)(6)-year-old man (case 1) reported bilateral hip pain with episodes of low-grade fever, 3 years after a pinnacle acetabular component with a cobalt chromium metal bearing surface (depuy) was implanted bilaterally.Pain was present since surgery and only short-term relief of pain after a one-month trial of prednisone.The patient subsequently had several episodes of low-grade fever, four weeks prior to presenting to emergency.Physical examination demonstrated a shuffling gait with the aid of two canes.The range of motion of both hips was limited to approximately 0 to 75 of flexion with pain on internal and external rotation.No external signs of infection were found.Radiographs of both hips revealed well-seated uncemented metal-on-metal total hip prostheses.The cup abduction angle was 47 on the left side and 50 on the right.The patient underwent extensive workups for inflammatory, rheumatologic, spine, and infectious etiologies, but no cause of the signs and symptoms was identified.Levels of cobalt (1.4 ng/ml [normal, 0.0 to 0.9 ng/ml]), chromium (0.4 g/l [normal, <0.3 mg/l]) were found elevated.Surgical exploration revealed stiff soft tissues and capsule with a ¿¿milk-stained¿¿ fluid within the joint and pathological examination of intraoperative tissue specimen showed chronic inflammation with perivascular lymphocytic aggregates consistent with aseptic lymphocytic vasculitis associated lesions (alval).The metal liner was exchanged for a highly cross-linked polyethylene liner.Post operatively, skin testing revealed a cutaneous allergic response to cobalt.8 months later, the patient reported substantial reduction of left hip pain and fever.Impacted product: pinnacle hip implant.

Manufacturer Narrative

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.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8890524
• MDR Text Key: 154278952
• Report Number: 1818910-2019-101027
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention