MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE H 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: partial femur cemented size 7 right medial item# 42558000702 lot# 64566408.Partial tibial cemented size h right medial item# 42538000802 lot# 64756151.Partial articular surface right medial size h 9 mm thickness.Item# 42528200809, lot# 64660777.Report source - (b)(6).Customer has indicated that the product will 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.
Event or Problem Description
It was reported that a trial articular surface was difficult to assemble with the tibial baseplate.The surgeon had left some tibial spine overhang (by using nibblers instead of saw), and the shelf of bone was preventing seating.Still more nibbling of spine and trial bearing finally seated.Surgeon wanted to use a 9mm, however defaulted to an 8mm due to overhang issue.Definitive articular surface was implanted in vivo after cementing femur and tibia.The articular surface seated easily with surgeon following prescribed technique.The rep observed the surgeon poking at the bearing with a howarth elevator and asked him if there was a problem.He stated that the bearing went in "too easily" and said that he felt there "was movement of the bearing on the baseplate posteriorly, like the bearing was for a bigger baseplate".The rep contacted the team member with the most experience with partial knees and was advised to remove the articular surface and replace it.The articular surface was very difficult to remove and sustained damage on removal.A 9mm bearing was used as another 8mm was not available.9mm bearing was a little more difficult to seat, but surgeon was happy that it was a better size.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The returned articular surface exhibited damage (nicked/gouged/cut) to the locking feature on the proximal and distal surfaces.Dimensional analysis or the product confirmed it was conforming to print specifications where measured.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE H 8 MM THICKNESS
• 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: 12746421
• Report Number: 0001825034-2021-03044
• Device Sequence Number: 19966072
• Product Code: HSX
• UDI-Device Identifier: 00880304818590
• UDI-Public: (01)00880304818590(17)250228(10)64660626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 42528200808
• Device Lot Number: 64660626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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
• Usage of Device: Initial
• 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
• Patient Sex: Male
• Patient Weight: 84 KG