MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; HIP ACETABULAR CUP

Catalog Number 121722050

Device Problems Malposition of Device (2616); Naturally Worn (2988)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Pain (1994); Synovitis (2094); No Information (3190); No Code Available (3191)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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

Patient was revised to address a malpositioned cup causing wear of the liner.Cup was noted to have been placed in 65 to 70 degrees of inclination.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient code: no code available (3191) used to capture the patient code blood heavy metal increased.

Event Description

Medical records received.After review of medical records, the patient was revised to address a failed total hip arthroplasty with pain, popping and clicking.There was some marked synovitis which had a darkish stain to it.The surgeon suspected that the patient was having problems with metal wear and metal debris.However, upon inspection of the neck trunnion, there was no significant wear on the neck trunnion.There were a couple of minor scratches but it was not considered significant.There was wear on cup and it was noted to be asymmetrical.The stem was noted to be stable and there was no evidence of loosening.Postoperatively, the patient had anemia due to blood loss.Two units were given to the patient.Lab results taken from (b)(6) 2015 show elevated cobalt and chromium levels.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5544650
• MDR Text Key: 41766695
• Report Number: 1818910-2016-16601
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2018
• Device Catalogue Number: 121722050
• Device Lot Number: CW4CG1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided; 08/30/2019; 08/10/2020
• Supplement Dates FDA Received: 05/20/2016; 09/05/2019; 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73