MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER WITH CONSTRAINING RING; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown stem.Unknown head.Unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04651, 0001822565-2019-04652.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to reduced mobility and a mri scan suggesting some localized tissue abnormalities around the hip prosthesis.Additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  a versys femoral head and a constrained liner were returned.Visual inspection of the constrained liner shows fractured pieces of tabs on the outer circumference.The broken pieces were not returned.With the information provided, it could not be determined if the fracture identified on the liner occurred in-vivo or during the removal process.The constrained ring showed scratches and nicks.Visual inspection of the head identified scratches on the bottom surface around the taper, and on the spherical surface.No other damages were noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: CONSTRAINED LINER WITH CONSTRAINING RING
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9255209
• Report Number: 0001822565-2019-04650
• Device Sequence Number: 19346462
• Product Code: KWZ
• UDI-Device Identifier: 00889024126084
• UDI-Public: (01)00889024126084
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071718
• 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): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00633405028
• Device Lot Number: 64165806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention