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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional information on reported event.

• Brand Name: LINER 26 MM I.D. FOR USE WITH 40/41 MM O.D. SHELLS
• Common Device Name: 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
• Report Number: 0002648920-2020-00182
• Device Sequence Number: 3153517
• Product Code: KWY
• UDI-Device Identifier: 00889024115231
• UDI-Public: (01)00889024115231(17)270228(10)64309539
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10