MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 BIOSTOP G CEM RESTR 14MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Catalog Number 546314000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

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

Occurrence: cement restrictor breaking at the time of use.Details: on (b)(6) 2018, in the total hip arthroplasty surgery, using the 14 mm bio cement restrictor, it was broken.According to reports this is not the first time this happens.For this new event, he called attention to record what happened.It was identified that the instruments used today in the c-stem amt stem box, "is not compatible with the plug (cement restrictor)".We request clarification as to the instruments and techniques of use so that the problem does not happen again.Product available for analysis.Product information: (b)(4) and lot: 16f1306005.

Manufacturer Narrative

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summaryexamination of the returned device confirmed the reported breakage.Based on the provided information and the preformed investigation, a definitive root cause cannot be determined.Depuy considers the investigation closed.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: BIOSTOP G CEM RESTR 14MM
• Type of Device: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY CMW ¿ 9610921 ; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7269835
• MDR Text Key: 100050127
• Report Number: 1818910-2018-53416
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295174578
• UDI-Public: 10603295174578
• Combination Product (y/n): N
• PMA/PMN Number: K943727
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 546314000
• Device Lot Number: 16F1306005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1