MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer avenir stem remover, cat#01.06808.300, lot#16.344435.Zimmer avenir broach, cat#01.06620.004, lot#14.074465.Zimmer avenir neck provisional, cat#01.06520.000b, lot#14.085140.Biomet calcar planner, cat#110032334, lot#770330.Biomet calcar planner shaft, cat#110032332, lot#711160.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 initial tha, trial head was stuck on avenir trial neck.The head would not disengage from the neck.No harm or injury to patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by visual inspection of returned product.Visual inspection identified wear and tear on the taper consistent with use over a potential field age of approximately 2 years 9 months.Dimensional analysis confirmed that the product identifiers were conforming to print specifications where measured.No other issues were identified.Review of the device history records and receiving inspection reports identified no deviations or anomalies during manufacturing related to the reported event.A supplier dhr was not requested as there was wear and tear all over the device and on the taper's surface that was consistent with use over a potential field age of approximately 2 years 9 months.Additionally, the inner diameter and depth of the taper were measured and were found to be conforming to print specifications.A definitive root cause cannot 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.

Event Description

No further event information available at this time.

• Brand Name: FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8886215
• MDR Text Key: 156585201
• Report Number: 0001822565-2019-03439
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00789503202
• Device Lot Number: 63686671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1