MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 7-8, UHMWPE PS, FIXED , H= 10 MM

Model Number	880-217/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lb was notified on 2022-05-17 by (b)(6).: "after attempting to impact the final poly spacer, it appeared to have been locked in place, but in reducing the knee into extension, the poly seemed disassociated posterior from tibia implant (lot # 1949231).The surgeon then removed the poly and requested a second one (lot # 1949232).With the second poly after appeared to not lock in the back after impacting, the surgeon requested a third poly.After cleaning out soft tissue and placing the knee in deep flexion, the poly locked in place.After closing the patient and performing rom the knee appeared to be stable and the surgeon appeared to be satisfied with the function of the knee.The processed added only a couple of minutes to the entire case." [customer].
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 re-evaluated 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.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 7-8, UHMWPE PS, FIXED , H= 10 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17040228
• Report Number: 3004371426-2023-00032
• Device Sequence Number: 6898219
• Product Code: HRY
• UDI-Device Identifier: 04026575253265
• UDI-Public: 04026575253265
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202924
• 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): 05/18/2022

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: 03/31/2026
• Device Model Number: 880-217/10
• Device Catalogue Number: 880-217/10
• Device Lot Number: 1949231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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