MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2020

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

Surgeon revising corail pinnacle for dislocation.Insitu was a ceramic liner which would not disassociate from the pinnacle sector cup.

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.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : 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(s) 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.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9779338
• MDR Text Key: 181735604
• Report Number: 1818910-2020-06607
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

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: 121881752
• Device Lot Number: 3132565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 03/25/2020
• Supplement Dates FDA Received: 03/12/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM; UNKNOWN HIP FEMORAL HEAD; APEX HOLE ELIM POSITIVE STOP; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM
• Patient Outcome(s): Required Intervention