MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE AXSOS 3 FOR LEFT TIBIA 2 HOLE / L95MM; PLATE, FIXATION, BONE

Catalog Number	627302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : hospital retained.
Event or Problem Description
"it was reported that the patient's right tibial proximal plate was revised due to pain and non-union.Plate was removed and a total knee was implanted.Rep can provide some images, otherwise confirmed that no further information will be released by the hospital or surgeon.".
Event or Problem Description
"it was reported that the patient's right tibial proximal plate was revised due to pain and non-union.Plate was removed and a total knee was implanted.Rep can provide some images, otherwise confirmed that no further information will be released by the hospital or surgeon.".
Additional Manufacturer Narrative
(b)(6)/ (b)(6) 2023: h4 /manufacturing date) was added.Correction - please refer to h6 clinical signs code.The reported event could be confirmed, since the lateral tibial joint line is impressed on the received x-ray.The devices were not returned for evaluation, therefore no device inspection was possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The provided information was forwarded to medical affairs for review with following feedback: "the lateral tibial joint line is impressed.However, it is difficult to assess whether malunion or nonunion has occurred, here.The positioning of the plate seems to be okay.Usually, beneath the plating in these tibial head fractures (likely schatzker type ii) there is a significant loss of subchondral bone substance.If that is not addressed with either augmentation of autologous bone or bone substitute, a failure is likely.As long as we do not have additional information this cannot be assessed safely." based on the available information it is not possible to define the root cause of this event.More detailed information, like pre- and-intra operative x-rays, operation reports and patient history, about the complaint event as well as the affected devices must be available for a complete assessment.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PROXIMAL LATERAL TIBIA PLATE AXSOS 3 FOR LEFT TIBIA 2 HOLE / L95MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17671560
• Report Number: 0008031020-2023-00330
• Device Sequence Number: 20373573
• Product Code: HRS
• UDI-Device Identifier: 07613252579328
• UDI-Public: 07613252579328
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627302
• Device Lot Number: H55892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 62 KG