MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED HIGH SIZE 6; HIP FEMORAL STEM

Model Number 1010-12-060

Device Problem Naturally Worn (2988)

Patient Problems Ossification (1428); Pain (1994)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle medical records received.After review of medical records patient was revised to addressed left hip polyethylene disassociation from pinnacle acetabular cup.Operative notes indicated pain and clicking sounds.On the polyethylene component, two of the locking flanges on the rim of the cup were broken off the cup.There was bone overgrowth the cup anteriorly.It was examined and felt there was a small scratches on the trunnion removing the femoral head component.Doi: (b)(6) 2019 ,dor: (b)(6) 2019, left hip.Please see (b)(4) for right 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, 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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS COLLARED HIGH SIZE 6
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12585084
• MDR Text Key: 275009536
• Report Number: 1818910-2021-22208
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380580
• UDI-Public: 10603295380580
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-12-060
• Device Catalogue Number: 101012060
• Device Lot Number: J09C06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED HIGH SIZE 6; ALTRX NEUT 32IDX52OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 52MM; ACTIS COLLARED HIGH SIZE 6; ALTRX NEUT 32IDX52OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 88