MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T3 LM; KNEE ENDOPROSTHETICS

Model Number NO164Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with as univation xf tibia.It was reported that as a result of having the product implanted, the patient has experienced left knee pain, a loss of mobility, and difficulty walking.The primary surgery occurred on (b)(6) 2017, and there was no reported revision surgery.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components no187z (as univation x femur cemented f3 lm).Nl472 (univation x pe insert t3 rm/lm 7mm).Np583r (threaded pin, headless 3.2mmx63mm).The cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).

Event Description

Associated medwatches: 2916714-2020-00232; 2916714-2020-00209; 2916714-2020-00210; 2916714-2020-00205.

Manufacturer Narrative

Internal notification number: (b)(4)-> (b)(4)/ (b)(4)/ (b)(4)/ (b)(4).Device: reference code (b)(4).Device name as univation xf tibia cemented t3 lm.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date unknown.Ref.Code device name batch nr.Manuf.Date no187z as univation xf femur cemented f3lm unknown unknown nl472 univation f meniscal comp.T3 rm/lm 7mm unknown unknown np583r threaded pin headless 3.2mm x 63mm unknown unknown investigation.Failure description.No product at hand.Therefore a failure description at the device is not possible.Investigation.No product at hand.Therefore an investigation at the product is not possible.Pictorial documentation.There are no pictures available.Batch history review.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale.In the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Conclusion and root cause.Based on the information available it is not possible to determine a possible root cause for the mentioned failure.Corrective action.This case is concerning implant loosening.For this topic (univation loosening) a product safety case (psc) was initiated.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T3 LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10231102
• MDR Text Key: 202410394
• Report Number: 2916714-2020-00232
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NO164Z
• Device Catalogue Number: NO164Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL472 - UNKNOWN.; NO187Z - UNKNOWN.; NP583R - UNKNOWN.
• Patient Outcome(s): Other