MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENT, INCL. TIBIAL PLATEAU, UNCEMENTED, COCRMO, UHMWPE, ROTATING

Model Number	16-2840/05
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.The report is delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we reevaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.
Event or Problem Description
On 2021-09-21, distributor was notified that during an sl hinge knee replacement on (b)(6) 2021, a connection component (part # 16-2840/05, sn # (b)(6) part description: connection component, rotational version, medium) did not properly deploy.The surgeon tried multiple times to get the locking screw to engage but was unsuccessful.However, a second identical device (part # 16-2840/05, sn # (b)(6)) "worked perfectly".As per the sales representative: "surgery time was only extended by a few minutes.Just long enough for us to go the storage room and get another medium connection component.The case ended up great".The complaint sample will not be available for investigation because "it fell into four or five separate pieces when it failed and was thrown away later".[customer].

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENT, INCL. TIBIAL PLATEAU, UNCEMENTED, COCRMO, UHMWPE, ROTATING
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17641842
• Report Number: 3004371426-2023-00085
• Device Sequence Number: 14850571
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 11/30/2025
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown