MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ALL POLY PAT COMP PRLG 32 DIA; PROSTHESIS, KNEE

Catalog Number	00597206632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right knee arthroplasty.Subsequently, the patient was experiencing pain and failed to progressively increase range of motion as expected with physical therapy.Approximately 6 weeks post implantation, a manipulation under anesthesia was completed with lysis of adhesions and successful return to an appropriate degree of range of motion.All initial components were retained.
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.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10; h11: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: during a follow-up office visit and pre-op evaluation for manipulation under anesthesia (mua), the patient reported sharp intermittent right knee pain rated 8/10.Examination showed the incision was clean, dry, and healing without drainage or erythema, with swelling decreasing.Alignment was normal, but range of motion (rom) was limited to 12¿70 degrees with extreme pain, and physical therapy had only achieved 75 degrees of flexion after 2¿3 sessions; mua was planned for the following day.Six weeks post-op, the patient underwent mua under general anesthesia due to limited improvement in rom.The knee was stiff at 70 degrees with a firm endpoint, but manipulation increased flexion to 105 degrees with gravity and 110 degrees with moderate pressure, with full extension achieved using moderate force.Lysis of adhesions was noted with soft popping sounds, and a right femoral nerve block was administered post-procedure.The patient tolerated the procedure well, recovered in stable condition, was discharged home with instructions for weight bearing as tolerated using a walker, pain management with medication and ice, and to begin physical therapy.A definitive root cause cannot be determined.This compliant can be confirmed based on the medical records provided.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.The following sections were updated: b4; b5; e1; g3; g6; h1; h2; h6.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was seen at a follow-up/pre-op visit, reporting sharp intermittent right knee pain rated 8/10.The incision was clean, dry, and healing without drainage or erythema, swelling was improving, and alignment appeared normal.Range of motion remained severely limited at 12¿70° with extreme pain, and pt reported only 75° flexion after several sessions, leading to a plan for manipulation under anesthesia (mua).Six weeks post-op, the patient underwent mua due to persistent limited rom (~70°).Under general anesthesia, stiffness was encountered at 70°, but manipulation achieved 105° flexion with gravity and 110° with moderate pressure, with full extension gained using firm force; soft popping consistent with lysis of adhesions was noted.A right femoral nerve block was administered, the patient recovered in stable condition, and was discharged home with wbat using a walker, pain control measures, and instructions to begin pt.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: NEXGEN ALL POLY PAT COMP PRLG 32 DIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21925742
• Report Number: 0001822565-2025-01185
• Device Sequence Number: 19854852
• Product Code: JWH
• UDI-Device Identifier: 00889024215207
• UDI-Public: (01)00889024215207(17)210831(10)63432275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2025

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: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 00597206632
• Device Lot Number: 63432275
• Was Device Available for Evaluation?: No
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 11/20/2025; 12/11/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 09/08/2025; 12/08/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 99 KG