MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722052

Device Problem Failure to Disconnect (2541)

Patient Problem Not Applicable (3189)

Event Date 02/14/2018

Event Type  malfunction  

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 impacted the cup and could not unscrew the impactor handle from cup he had to remove the cup.Another surgeon came in and also tried to unscrew cup from handle, but could not do it.The surgeon had to open new instr set to get another impactor cup handle and had to ream to next size as first cup removal did affect cup size.All this did not cause any harm to patient but delayed case for about 30 minutes.I have tried impactor handle on another dni cup i have and it seems ok.It looks that the threads that were damaged during impaction were the ones in the cup but unfortunately, sterilization did not keep the cup after they finally unscrewed it from the handle with pliers.I can return impactor handle but no cup.Pls replace asap to just.(b)(6).Po: (b)(4).One ea 221750041, one ea 121722052.Ps: the same thing happened on (b)(6), (b)(4), in a different hospital, same size cup but different lot #.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.  product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7337255
• MDR Text Key: 102338072
• Report Number: 1818910-2018-55022
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121722052
• Device Lot Number: 8660215
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1