MAUDE Adverse Event Report: AESCULAP AG UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; KNEE ENDOPROSTHESES

Model Number NL471

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

Event Date 05/18/2020

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 product univation f meniscal comp.T2 rm/lm 7mm.According to complaint description it was reported that implants loosened postoperatively (po) due to no contact with the cement or had no adhesion of any cement residues.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00191 ((b)(4) - no186z), 9610612-2020-00192 ((b)(4) - no163z).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00191 (100025545 ((b)(4)) - no186z); 9610612-2020-00192 (100025545 ((b)(4)) - no163z); 9610612-2020-00193 (100025545 ((b)(4)) - nl471).General information: we received a complaint regarding univation implants.The complained devices were delivered in an unknown hygienic status, therefore the components were decontaminated internally according to internal standards.Consequences for the patient: post-operative medical intervention was necessary -> revision surgery.Investigation: the components have been examined visually with the digital-camera "panasonic dmc tz8".No abnormalities or damages were found on the coated surface of the implants.In the delivered condition, there are no bone cement residues visible on the implants the gliding surface of the meniscal component shows visible scratches and imprints probably resulting from third body wear (bone chips and/or bone cement residues.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure.It could be possible that the failure is usage related.Rationale: on the basis of the current information, a clear conclusion can not be drawn.The device history records have been checked and no abnormalities could be observed.There are no hints for a material/device problem.It could be possible that there were problems with the cement technique.Potential sources of faults relating to the cement: · the processing time of the used cement was exceeded; · wrong temperature; · unfavourable storage; · the age of the cement; · wrong handling with the cement.Corrective action: product safety case was created.

• Brand Name: UNIVATION F MENISCAL COMP.T2 RM/LM 7MM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10133274
• MDR Text Key: 197604753
• Report Number: 9610612-2020-00193
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K081293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: NL471
• Device Catalogue Number: NL471
• Device Lot Number: 52181465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention