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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.(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 abstract entitled, ¿impact of a learning curve on the survivorship of 4802 cementless total hip arthroplasties¿ by p.Magill, et al, published by the bone and joint journal (2016), vol.98-b, no.12, pp.1589-1596, was reviewed.The purpose of this study is to report survivorship data and lessons learned with the corail/pinnacle cementless total hip arthroplasty (tha) system implanted between august 2005 and march 2015.Implanted depuy products: corail stem, pinnacle cup, and a variety of bearings: com, mom, coc, cop, and mop.Results: 22 revisions for joint instability- 20 head and liner exchanges; 1 cup, head, liner, and stem exchange; 1 cup, head, and liner exchange.20 revisions for infection- 10 head and liner exchanges; 10 cup, head, liner, and stem exchanges.15 revisions for aseptic stem loosening- 4 cup, head, liner, and stem exchanges; 11 head, liner, and stem exchanges.6 periprosthetic intraoperative femoral fractures that were unrecognized during index surgery and treated postoperatively- 5 treated with head and stem revision; 1 treated with orif.6 liner disassociations- 4 treated with head and liner exchanges and 2 treated with head, liner, and cup exchanges.5 cases of metallosis associated with com and mom bearings- 2 treated with head and liner exchange; 2 treated with head, stem, and liner exchange, and 1 treated with head, liner, and cup exchange.1 cup, head, liner, and stem revision due to a fall.2 cup, head, liner, and stem revisions due to dislocation.1 acetabular fracture treated with revision of the cup, head, and liner.1 aseptic loosening of the cup treated with revision of the cup, head, and liner.1 leg length discrepancy treated with revision of the head and stem.Captured in this complaint: 35 corail stems: implant loosening, fracture intra-op, limb asymmetry, inadequate osseointegration.17 pinnacle cups: implant loosening, fracture post op, inadequate osseointegration.56 acetabular liners: implant bearing wear, implant dislocation, implant disassociation, joint dislocation, foreign body reaction.51 femoral heads: implant bearing wear, implant dislocation, foreign body reaction, joint dislocation, limb asymmetry.Patient harms applied to all components: infection, joint instability, fall, medical device removal, surgical intervention.

Manufacturer Narrative

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.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 (b)(4).

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.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, 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: 9395962
• MDR Text Key: 185008663
• Report Number: 1818910-2019-118338
• 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,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention