MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 26 MM I.D. FOR USE WITH 40/41 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00500104100-shell 41 mm o.D.- 64257738.Unknown-unknown stem-unknown.Unknown-unknown head-unknown.Foreign report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, during the surgery, when opening the sterile package, the locking ring of the liner came off the liner body.The surgery was finished with a backup multipolar.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device identified that the split ring was separated from the liner.However, the ring assembled with the liner as intended.No other issues were identified.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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 additional information on reported event.

• Brand Name: LINER 26 MM I.D. FOR USE WITH 40/41 MM O.D. SHELLS
• 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: 9855863
• MDR Text Key: 190788841
• Report Number: 0002648920-2020-00182
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115231
• UDI-Public: (01)00889024115231(17)270228(10)64309539
• 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: 04/28/2020

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: 00500104026
• Device Lot Number: 64309539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10