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

Catalog Number 121722052

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 01/17/2018

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 could not unscrew impactor handle from cup once implanted.He had to remove handle with cup still attached to it.No parts fell into patient.Case delayed about 30 minutes total, trying at first to unscrew handle, then getting new handle from another instrument set.The surgeon also opened a second cup to replace original one.Pls replace both items under po: (b)(4).Patient consequence?: no.Action taken for procedure:used another handle from another instr set and a new cup.

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.Investigation summary: examination of the returned instrument cannot confirm the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7273927
• MDR Text Key: 100179857
• Report Number: 1818910-2018-53497
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

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: 121722052
• Device Lot Number: 8645087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention