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); Naturally Worn (2988)

Patient Problems Osteolysis (2377); Not Applicable (3189); No Code Available (3191)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

Literature article entitled, ¿osteoclasts in periprosthetic osteolysis: the charnley arthroplasty revisited¿ by sebastian s.Mukka, md, phd, et al, published by the journal of arthroplasty (2017), vol.32, pp.3219-3227, was reviewed.The present aim was to study osteoclast occurrence in osteolytic lesions in early and late revisions of the charnley low-friction torque arthroplasty (clfa).The authors took biopsies of the osteolytic lesions during revision and performed microscopic analysis of the excised tissue.All revisions were performed due to aseptic loosening of the acetabular or femoral components.Implanted products: 16 cementless charnley stems and 14 cemented charnley cups were revised for aseptic loosening due to osteolysis.The femoral head information was not provided by assumed to be a depuy product.Results: histological analysis of the excised bone tissue revealed extensive polyethylene particulates and inflammatory markers associated with osteolysis formation attributed to polyethylene wear.The authors discovered evidence of low-grade chronic inflammation and osteoclast-like cells associated with bone resorption.Intraoperatively, 1 stem was found to have migrated into varus.The explanted polyethylene cups showed evidence of polyethylene wear.There was no reported product problem with the femoral head.The loosening of the cemented polyethylene cup was attributed to the acetabular osteolytic lesions consistent with polyethylene wear particulates.Captured in this complaint: charnley polyethylene cup, femoral head, and charnley femoral stem.

Manufacturer Narrative

Product complaint # (b)(4).H6 patient code: not applicable (3189) used to capture medical device removal.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.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: no.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.A review of complaint databases was not possible as no product details were received.It should be noted that no device was returned.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.

• 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: 9329476
• MDR Text Key: 182802674
• Report Number: 1818910-2019-115089
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention