MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THN 34 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).Concomitant medical products: item#:195924; vgxp intlk femoral lt 70; lot#:057900.Item#:195275; vngd xp cr intlk tib tray 75mm; lot#:206860.Item#:195557; vgxp as e1 tib brg lm/rl 10x75; lot#:598480r.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.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: 0001825034-2020-00769.0001825034-2020-00770.0001825034-2020-00771.
Event or Problem Description
It was reported the patient was experiencing stiffness and had a mua performed on his left knee approximately four months post-op.
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.Reported event was unable to be confirmed due to limited information received from the customer.This complaint was not confirmed.Device history record (dhr) reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.Mymobility records were provided and reviewed by a healthcare professional.Review found patient was full weight bearing and no pain (b)(6) 2019.Mua performed on (b)(6) 2019 due to stiffness.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a healthcare professional.Review found patient had full extension with flexion limited to 90 degrees.Mua performed on 23-aug-2019 due to stiffness and arthrofibrosis.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SERIES A PAT THN 34 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9722474
• Report Number: 0001825034-2020-00772
• Device Sequence Number: 18924118
• Product Code: JWH
• UDI-Device Identifier: 00880304436749
• UDI-Public: (01)00880304436749
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 184786
• Device Lot Number: 756240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 09/02/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/14/2020; 09/03/2020
• 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; Other
• Patient Weight: 104