MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-052

Device Problem Migration (4003)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/30/2020

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

Revision of right thr; primary implant date: (b)(6) 2019 (right corail/pinnacle total hip replacement).Reason for revision: pain and loss of mobility, due to acetabular medial migration, secondary to bone tumour.Patient presented to surgeon with painful right hip and difficulty mobilizing.Subsequent x-ray revealed a secondary bone tumour in the patients right side of pelvis.The acetabular component had subsequently migrated medially.Surgeon removed the acetabular component and proceeded to reconstruct the pelvis.The surgeon stated the femoral component was well fixed and was not revised.There was no delay to surgery and no ae to patient.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Additional narrative:  product complaint # (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10048637
• MDR Text Key: 190675804
• Report Number: 1818910-2020-11993
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: 8755930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; CORAIL AMT COLLAR SIZE 12.; DELTA CER HEAD 12/14 36MM +5.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN MAR +4 10D 36IDX52OD.; APEX HOLE ELIM POSITIVE STOP; CORAIL AMT COLLAR SIZE 12; DELTA CER HEAD 12/14 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 10D 36IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR