MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-054

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Adhesion(s) (1695); Injury (2348); No Code Available (3191)

Event Date 01/12/2006

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.(b)(4).Initial reporter occupation: lawyer.

Event Description

After review of medical records, it was noted that patient had a standard cdh acetabulum and a revision was performed due to acetabular component failure; the screws sheared off and the cup was dislocating out of the acetabulum.Revison notes reported that the cup grossly failed.There were notable scar tissues and bone loss on the acetabulum.There was also an incomplete union at the osteotomy site of the femur and this was then cabled.This can also be referenced to the initial hip surgery, wherein a small crack in the proximal femur occurred during the insertion of the femoral component which required cabling and bone grafting.Doi: (b)(6) 2005; dor: (b)(6) 2006 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Correcting the data in (device codes) to migration.

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.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.

• Brand Name: PINNACLE SECTOR II CUP 54MM
• 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: 9729358
• MDR Text Key: 185330905
• Report Number: 1818910-2020-05365
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009832
• UDI-Public: 10603295009832
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2010
• Device Model Number: 1217-22-054
• Device Catalogue Number: 121722054
• Device Lot Number: ZF3ET1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR