MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 31 3 PEG; PROSTHESIS, KNEE

Catalog Number	184764
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05725.0001825034-2019-05726.Concomitant medical products: (b)(6) 2019.189040 - vngd ant stblzd brg - 689350, 141222 - biomet cc i-beam tray - j6422080, 184764 - series a pat std 31 3 peg - 817600, unknown palacos cement.No devices or photos were received; therefore the condition of the components is unknown.No compatibility issues were noted.Office visit notes for three month visit state that patient had moderate stiffness, tight laxity and rom 10-100 degrees.Patient underwent manipulation under anesthesia for left knee arthrofibrosis.The preop rom was 5-95 degrees and postop rom was 0-135 degrees.There were no intraop complications.Postop and intraop xrays reviewed and noted that all components were found to be in satisfactory position and alignment.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot be determined.If any further information 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
It was reported that the patient underwent manipulation under anesthesia 10 weeks post implantation due to stiffness and limited extension.The outcome was reported as tolerated with no further complications.

• Brand Name: SERIES A PAT STD 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9769596
• Report Number: 0001825034-2020-00940
• Device Sequence Number: 2786767
• Product Code: JWH
• UDI-Device Identifier: 00887868344084
• UDI-Public: (01)00887868344084
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/27/2020

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: 03/14/2024
• Device Catalogue Number: 184764
• Device Lot Number: 817600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/28/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Weight: 86