MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BIPOLAR LINER; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00500104000, bipolar metal shell, lot # 62687743; 00801802605, femoral head, lot # 62568410.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2018-00026, 00027, 00028.

Event Description

It was reported that the bipolar components were being assembled on the back table by the surgical technician during a hip hemiarthroplasty prior to the initial implantation.It was discovered that the femoral head would not snap into the bipolar liner, and would not freely spin.Further, when trying to insert the liner/head into the bipolar shell, it would not fit properly.The event had no patient involvement.No further information is available.

Event Description

It was reported that the bipolar components were being assembled on the back table by the surgical technician during a hip hemiarthroplasty prior to the initial implantation.It was discovered that the femoral head would not snap into the bipolar liner, and would not freely spin.Further, when trying to insert the liner/head into the bipolar shell, it would not fit properly.The event had no patient involvement.No further information is available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.As returned, the femoral head was assembled to the liner.The split ring had migrated from it¿s intended position.Two witness marks are seen on the ring where it came into contact with the shell during attempted impaction.Dimensional analysis on the liner cannot be performed due to it¿s attempted impact.The femoral head dimensional analysis was performed and was conforming to specifications.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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: ZIMMER BIPOLAR LINER
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7179357
• MDR Text Key: 97800065
• Report Number: 0002648920-2018-00027
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00500104026
• Device Lot Number: 62473490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1