MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS WEDGE - 7 X 18; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6465-6-007
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Revision (hmrs parts replacement after 12 years) according to bfarm special approval 92.16-5640-s-023/22.Update 25may22: after 12 years , the poly is worn out.There was a massive instability in the knee joint.Especially the stopper on the proximal tibia was very crushed.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture, wear, and instability involving a hmrs wedge was reported.The crack/fracture and wear events were confirmed via evaluation of the returned device.Instability was not confirmed.Method & results: -product evaluation and results: visual inspection: the damage present on the hmrs wedge is consistent with delamination and material loss; which are common damage modes of uhmwpe.The wedge appears to have split open.Hackles are observed on the fractured surface are consistent with a fracture in overload.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to worn poly components and joint instability, a "crushed" stopper was also reported.The damage present on the hmrs wedge is consistent with delamination and material loss; which are common damage modes of uhmwpe.The wedge appears to have split open.Hackles are observed on the fractured surface are consistent with a fracture in overload.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.
Event or Problem Description
Revision (hmrs parts replacement after 12 years) according to bfarm special approval 92.16-5640-s-023/22.Update 25may2022.After 12 years , the poly is worn out.There was a massive instability in the knee joint.Especially the stopper on the proximal tibia was very crushed.

• Brand Name: HMRS WEDGE - 7 X 18
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14674068
• Report Number: 0002249697-2022-00823
• Device Sequence Number: 17547200
• Product Code: KRO
• UDI-Device Identifier: 07613327048933
• UDI-Public: 07613327048933
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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 Model Number: 6465-6-007
• Device Catalogue Number: 64656007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male