MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Corroded (1131)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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

Literature article entitled, ¿fracture of a ceramic femoral head after a revision operation: a case report¿ (january 1997) by ian t.Pulliam, do, et al, published in the journal of bone and joint surgery vol.79-a no.1 pp.118-121 was reviewed for mdr reportability.The article presents the case of a single patient who underwent two revision surgeries following thas with depuy products.The first revision, in september 1993, was due to extensive wear of the polyethylene liner and substantial, radiographically diagnosed, osteolysis of the acetabulum and proximal portion of the femoral neck after primary tha with an aml cementless medullary locking prosthesis.The intraoperative findings revealed diffuse corrosion, a fractured polyethylene component, and a scored femoral head and acetabular cup.The surgically confirmed osteolysis of the acetabulum required the insertion of morselized allograph and an acetabular reinforcement ring (ganz, protek ag, berne, switzerland) for stabilization of the revision products.The revision implants were: 58-mm all-polyethylene cup (unknown manufacturer), a 28-mm zirconia ceramic femoral head with a +3-mm offset (depuy).The original femoral component was left in situ.One year following the initial revision surgery, the patient heard, and audible pop followed by pain.The second revision surgery revealed a fractured ceramic femoral head with wear along the taper and inside the femoral head.The ceramic head was replaced with a cocr femoral component with a +5-mm offset.The cup, liner, and femoral stem were left in situ with no evidence of defect or malfunction contributing to the event.Country of origin: usa.Adverse event(s) related to product(s): fractured polyethylene cup (revision 1).Corrosion (revision 1)-stem, head, cup, and liner.Worn femoral head (revision 1).Worn acetabular shell (revision 1).Osteolysis (revision 1).Implant noise (revisions 1&2).Fractured femoral head (revision 2).Metal debris (femoral head and stem revision 2).Patient(s) reported harm(s) prior to procedure: revision 1: pain, surgical intervention.Revision 2: pain, surgical intervention.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 #: (b)(4).Investigation summary: 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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8898366
• MDR Text Key: 155419588
• Report Number: 1818910-2019-101266
• Device Sequence Number: 1
• Product Code: KWY
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention