MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source: (b)(6).Concomitant medical products: unknown head, unknown.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 hip procedure, the 28mm head could not be put into the liner.No additional information available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Review of the lock ring upon removal from the liner showed the taper feature that goes around the entire ring is not present.Due to the evaluation of the returned unit of the complaint, it was confirmed the missing chamfer feature which was attributed to excess of accumulated chips on the tool that performs the cut.Dhr was reviewed and no discrepancies were found.Root cause is determined to be manufacturing deficiency.No additional actions are required as the appropriate controls were already in place during the time of manufacturing.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 the time of this report.

• Brand Name: LINER 28 MM I.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
• MDR Report Key: 8493427
• MDR Text Key: 141322319
• Report Number: 0002648920-2019-00256
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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: 00500104728
• Device Lot Number: 64132104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1