MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); 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.(b)(4).

Event Description

"literature article entitled, ¿trochanteric union in revision hip arthroplasty¿ by p.Nicholson, et al, published by the journal of arthroplasty (2001), vol.16, no.1, pp.65-69, was reviewed.The purpose of this article was to present a series of 69 patients who have undergone repeated transtrochanteric osteotomy to determine if it is associated with a higher nonunion rate and poorer clinical outcome.All 69 hips were implanted between 1988-1995 with cemented charnley thas.The manufacturer of the cement is unknown.The total number of depuy charnley components implanted between 1990-1995 is unknown.Implanted depuy products: charnley polyethylene cup, cocr femoral head, and charnley stem.The cup and stem were cemented with unknown cement.Results: 56 cups and stems revised for aseptic loosening.There is insufficient information provided to determine the interface of the aseptic loosening of the cups and stems cemented with unknown cement.13 cups and stems revised due to septic loosening of an unknown interface.1 dislocation treated with closed reduction.There were 15 cases of non-union of the trochanter identified intraoperatively during revision surgery.In 4 cases, there was stem migration secondary to non-union of the trochanter at the osteotomy site.Captured in this complaint: 13 cups: implant loosening of an unknown interface, implant dislocation.13 stems: implant loosening of an unknown interface, implant migration.Harms: surgical intervention.Medical device removal.Symptoms: infection, joint dislocation, bone injury.".

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 # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9627079
• MDR Text Key: 186455234
• Report Number: 1818910-2020-02765
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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 ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention