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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN COCR METAL-BACKED PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN COCR METAL-BACKED PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problems Material Erosion (1214); Fracture (1260); Material Deformation (2976)
Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
Event Date 02/03/2020
Event Type  Injury  
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.Device not returned.
 
Event Description
It was reported that the patient's left knee was revised after patient complaint of pain and audible crepitus.Intra-operatively, it was noted that the poly portion of the cocr patella had a vertical split and had delaminated completely from the metal backing.As a result, metallosis as a result of the metal portion of the patella articulating with the cocr femoral component was observed.The patellar component and 6x11 cr insert were revised (there are no allegations against the revised insert).The femoral component was not revised as no wear was observed.Rep can provide explant pictures, and confirmed that no further information will be available.
 
Event Description
It was reported that the patient's left knee was revised after patient complaint of pain and audible crepitus.Intra-operatively, it was noted that the poly portion of the cocr patella had a vertical split and had delaminated completely from the metal backing.As a result, metallosis as a result of the metal portion of the patella articulating with the cocr femoral component was observed.The patellar component and 6x11 cr insert were revised (there are no allegations against the revised insert).The femoral component was not revised as no wear was observed.Rep can provide explant pictures, and confirmed that no further information will be available.
 
Manufacturer Narrative
Reported event: an event regarding crack/fracture and metallosis involving an triathlon metal backed patella was reported.The reported crack/fracture was confirmed, through photograph provided, however the reported metallosis was not confirmed.Method & results: device evaluation and results: the reported device was not returned for evaluation however photographs were provided for review.The patella poly and metal portions are detached from each other.The superior surface of poly portion is pictured and it has a crack down the center of it and there is a piece missing.The inferior surface of the metal portion is pictured.There is evidence of what appears to be bony in-growth on a large portion of the surface with biological material.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
 
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Brand Name
UNKNOWN COCR METAL-BACKED PATELLA
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9775863
MDR Text Key185011458
Report Number0002249697-2020-00442
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight93
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