MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Mfr for associated product, acetabular cup: 0001825034-018 -03321.

Event Description

It was reported that upon inserting screw into cup, the screw went all the way through the holes.Surgeon removed the devices and completed the surgery with new devices.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The returned device showed threads of the screw hole of the shell are damaged.Due to the damage both go and no-go thread gage did not mate with the screw hole of the shell.The head of the screw is heavily damaged and appears to have indications of the shell thread gouged into it.Due to the screw head damage, the screw did not pass through when the screw is straight in the hole but when it is held at an angle it passes through.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7513656
• MDR Text Key: 108228690
• Report Number: 0002648920-2018-00408
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: 63989403
• Other Device ID Number: (01) 00889024119602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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
• Treatment: 010000661 / 6062452 CUP
• Patient Outcome(s): Required Intervention