MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 J-FX BIPOL SHELL&28MMLINR/54MM; MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 856754

Device Problem Fitting Problem (2183)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

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 surgeon failed to lock the implant because the surgeon could not operate the lock mechanism smoothly during the surgery on (b)(6) 2018.The surgeon could not insert to the cup completely although apply more force to the assembly tool more than usual.The surgery was completed by using alternative cup (same size, p/n and lot number were unknown).There was less than 30min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.Product problem has not been identified.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.

• Brand Name: J-FX BIPOL SHELL&28MMLINR/54MM
• Type of Device: MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7490042
• MDR Text Key: 107600515
• Report Number: 1818910-2018-58963
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K980801
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856754
• Device Lot Number: D16010728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/30/2018; 09/30/2018
• Supplement Dates FDA Received: 05/23/2018; 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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