MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE SIZE EF 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Impaired Healing (2378); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address pain, swelling and suspected infection approximately five (5) weeks post-operatively.The articular surface was removed, however, the new articular surface was unable to be seated, so the surgeon opted to reuse the original articular surface after it was sterilized.Initial operative notes noted no intraoperative complications.Revision operative notes noted that poor healing, necrosis and effusion were found.The original articular surface was soaked several times in hydrogen peroxide and iodophor and rinsed with saline before it was re-inserted.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant devices - nexgen stemmed precoat cemented tibial component size 3 catalog #: 00598003701 lot #: 65550560, nexgen posterior stabilized standard cemented femoral component left size 7 catalog #: 42500606201 lot #: 65335356, nexgen straight stem extension 12.7mm x 30mm catalog #: 00598801212 lot #: 65584578 report source - foreign: event occurred in china.The complainant has indicated that the product will not 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
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.Medical records were received and reviewed.The device history records were reviewed and no discrepancies were identified.The instructions for use for the articular surface instruct the following: "do not reinsert an articular surface implant that has been inserted previously.There may be visually nondetectable flaws that could reduce the service life of the implant." however, a definitive root cause regarding the revision 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.Multiple mdr reports were filed for this patient; please see all reports associated with this patient: 0001822565-2023-01056; 0001822565-2023-01217.

• Brand Name: NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE SIZE EF 10MM
• 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: 16896649
• Report Number: 0001822565-2023-01217
• Device Sequence Number: 6092301
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)270905(10)65486328
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/26/2023

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 Model Number: N/A
• Device Catalogue Number: 00596203210
• Device Lot Number: 65486328
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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): Yes
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG