MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX ARTICULAR SURFACE SIZE GH 10MM; 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	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not fit to mating component.Another device was used to complete the surgery.No further information is available.
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface use with lps/lps-flex 51 or 52 suffix femorals size gh 12 mm height catalog # 00596205012 lot # 65292341, stemmed nonaugmentable tibial component option cr/ps/lps size 7 for cemented use only catalog # 00598605701 lot # j6752249, femoral component option for cemented use only size g catalog # 00599601702 lot # 64260546.Phone number: (b)(6).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h10.The following sections were corrected: b5, d1 visual examination of the returned articular surface showed the dovetail feature was compressed and flared out.Nicks and gouged were also seen on the distal surface, likely occurring during the multiple attempts made to seat the device.The device history records were reviewed and no discrepancies were identified.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented prior to insertion.Detailed instructions for insertion are included within the surgical technique.Additionally, investigation of the components used confirmed the articular surface used was not compatible with the femoral component.Per the package insert, it is indicated that lps or lps-flex femoral components are not to be used with lps-flex prolong articular surfaces unless the part number of the femoral component has a 51 or 52 part number suffix.Use of these incompatible devices may increase the risk of articular surface spine fracture.The root cause of the reported event is attributed to unintended use error and failure to follow instructions.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.
Event or Problem Description
It was reported during knee arthroplasty that the articular surface did not seat in the tibial tray after several attempts.Another articular surface was used to complete the surgery.No further information is available.

• Brand Name: NEXGEN LPS-FLEX ARTICULAR SURFACE SIZE GH 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: 14874187
• Report Number: 0001822565-2022-01906
• Device Sequence Number: 5249510
• Product Code: JWH
• UDI-Device Identifier: 00889024211421
• UDI-Public: (01)00889024211421(17)250902(10)64808574
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173057
• 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): 10/26/2022

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: 09/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 00596205010
• Device Lot Number: 64808574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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 NARRATIVE
• Patient Sex: Male
• Patient Weight: 98 KG