MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE; PROSTHESIS, KNEE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, the patient underwent revision surgery of the articular surface for an unknown reason.Due diligence is complete as multiple attempts were made; however, no further information or product has been received.

Manufacturer Narrative

(b)(4).Medical product: unknown rotating hinge knee femoral component: catalog#ni, lot#ni; unknown rotating hinge knee tibial tray: catalog#ni, lot#ni; unknown rotating hinge knee femoral stem: catalog#ni, lot#ni.Report source: foreign country: germany.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post implantation, the patient underwent revision surgery for a debridement and articular surface exchange due to increasing pain and a history of septic complications.There was no evidence of infection found during the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b4; b5; b7; e1; g3; h2; h6; h10.Additional information provided prompted a review of the investigation, which is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post implantation, the patient began to experience increasing pain.Due to a history of septic complications, the patient was then scheduled for a debridement procedure with an articular surface exchange.There was no evidence of infection found during the procedure, though a bone resorption zone was augmented with cement.The articular surface was not explanted.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated/corrected: b4; b5; d6b; g3; h2; h3; h6; h10.D6b: the device was not explanted.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.H3 other text : see h10 narrative.

• Brand Name: UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE
• Type of Device: 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: 15300036
• MDR Text Key: 298664509
• Report Number: 0001822565-2022-02471
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 86 KG