MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OFFSET ADAPTER 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6478-6-490
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : not available.
Event or Problem Description
The following was reported, "5th june case: the femoral component was removed and the stem had fractured off at the junction of the 4mm offset adapter.The tibial component was retained and a gmrs distal femoral construct was implanted.".
Event or Problem Description
The following was reported, "5th june case: the femoral component was removed and the stem had fractured off at the junction of the 4mm offset adapter.The tibial component was retained and a gmrs distal femoral construct was implanted.".
Additional Manufacturer Narrative
An event regarding crack/fracture involving a duracon adapter was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that the offset adapter has fractured where the bolt meets the body of the device.Extensive mechanical damage is visible on the fractured surfaces as the areas appear smooth and worn, consistent with the fractured surfaces pressing against each other while implanted.Additional damage in the form of black discoloration is visible on the body of the offset adapter, which appears consistent with the head of the bolt articulating against the body of the adapter either after or leading up to final fracture.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the stem adapter.Visual inspection of the returned devices indicated that the offset adapter has fractured where the bolt meets the body of the device.Extensive mechanical damage is visible on the fractured surfaces as the areas appear smooth and worn, consistent with the fractured surfaces pressing against each other while implanted.Additional damage in the form of black discoloration is visible on the body of the offset adapter, which appears consistent with the head of the bolt articulating against the body of the adapter either after or leading up to final fracture.Further information such as pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: OFFSET ADAPTER 4MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17213348
• Report Number: 0002249697-2023-00723
• Device Sequence Number: 7241071
• Product Code: KRO
• UDI-Device Identifier: 07613327050257
• UDI-Public: 07613327050257
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 6478-6-490
• Device Catalogue Number: 64786490
• Device Lot Number: S3JCC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2011
• 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; Hospitalization
• Patient Sex: Unknown