MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 28MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 141205, biomet tibial locking bar, lot#: 588070 item#: 141314, biomet finned pri stem 40mm, lot#: 761940.Item#: 141271, bmet regenx pri tib tray 63mm cocr 63mm, lot#: 030910.Item#: ep-183626, e1 vngd ps tib brg 63/67x16 x 16, lot#: 984900.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03094, 0001825034-2020-03093, 0001825034-2020-03091, 0001825034-2020-03090.
Event or Problem Description
Patient¿s legal counsel reported patient underwent left knee arthroplasty four years ago.Legal counsel further reports patient underwent a revision procedure six months ago for unknown reasons.
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.Updated: b4, b5, g4, h2, h3, h6, h10.D11: medical products: pn: 184520, vngd ps open por fmrl lt, ln: 966170 reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned patella found signs of being implanted wear/discoloration / foreign material and all three of the posts have fractured off.The remaining devices were not returned for evaluation.Was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RGX 3 PEG SER A PATELLA 28MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10374904
• Report Number: 0001825034-2020-03092
• Device Sequence Number: 16938304
• Product Code: JWH
• UDI-Device Identifier: 00880304554405
• UDI-Public: (01)00880304554405
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 141355
• Device Lot Number: 006170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/16/2020; 01/21/2022
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/22/2020; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female