MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BIPOLAR METAL SHELL 46 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Detachment Of Device Component (1104); Difficult to Insert (1316); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

During a procedure, there was difficulty assembling the acetabular cup with the liner on the back table.After attempting to assemble two different liners, it was discovered that the locking ring was bent inside of the acetabular cup and tabs in the cup were not aligned properly.Another cup and liner were used to complete the procedure without a significant delay.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00500104428, bipolar liner, 63181031, 00500104428, bipolar liner, 63431201, 00801802802, versys femoral head, 63482107, 00801802802, versys femoral head, 63482109.Complaint sample was evaluated and the reported event was confirmed.A bipolar shell, and two bipolar liners were returned for evaluation.As returned, one of two tabs of the lock ring is seized in the lock ring groove of the bipolar shell.Both liners exhibit damage that indicates the lock ring tab was not in its¿ intended position prior to the attempt to install the liners.Dimensional readings of the lock ring and lock ring groove are conforming to print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIPOLAR METAL SHELL 46 MM O.D.
• 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: 6337741
• MDR Text Key: 67655509
• Report Number: 0002648920-2017-00062
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00500104600
• Device Lot Number: 62430399
• Other Device ID Number: (01) 00889024115347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 91 YR