MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR BIPOLAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The following sections could not be completed with the limited information provided.Unique identifier (udi) # - (b)(4).Medical product ¿ biomet echo femoral, catalog#: 12-150313, lot#: 907150.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a procedure, the acetabular liner would not assemble with the acetabular cup.The surgery was finished with an alternative product without patient injury or significant delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical product: unknown head, catalog#: ni, lot#: ni.Unknown liner, catalog#: ni, lot#: ni.Unknown stem, catalog#: ni, lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Step by step assembly instruction and instruction for checking the position and condition of the locking ring prior to assembly are provided both in the multipolar bipolar cup surgical technique and package insert.There is also instruction for checking the position and condition of the locking ring prior to assembly in both the documents.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: MULTIPOLAR BIPOLAR CUP
• 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: 6432585
• MDR Text Key: 70868661
• Report Number: 0002648920-2017-00203
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00500104400
• Device Lot Number: 63454535
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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