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 Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 05/09/2020

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

It was reported that the patient came into the er at (b)(6) with hip pain.The surgeon was assigned the consultation and the xrays revealed the patients' acetabular cup was loose.The only information he had was that a dr.(b)(6) at (b)(6) hospital replaced this patients hip in 2013.Surgeon revised this patients hip by explanting the pinnacle liner, sector cup, acetabular screw, hole eliminator, and femoral hip ball.A new acetabular cup and liner were implanted with 3 screws and a new femoral hip ball was implanted.The patients' femoral stem which was a depuy aml stem was left in situ.Doi: 2013; dor: (b)(6) 2020; left hip.

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 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.H10 additional narrative:  corrected: h6 (device).

• 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: 10100844
• MDR Text Key: 193047472
• Report Number: 1818910-2020-12828
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009832
• UDI-Public: 10603295009832
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/09/2020

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 Model Number: 1217-22-054
• Device Catalogue Number: 121722054
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 67