MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/12/2022
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.Device not returned.
Event or Problem Description
It was reported by a surgeon that the patient had a broken implant.The primary surgery was completed on (b)(6) 2007 and the first revision surgery was completed on (b)(6) 2017.The broken implant was found one month prior to the second revision surgery.The second revision surgery was completed on (b)(6) 2022.This report is for the second revision.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an mrs stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm that these events occurred since i was able to see a preoperative x-ray, intraoperative x-rays, initial postoperative x-rays, and post-revision x-rays.This assumes that all of these documents pertain to the patient we are discussing.Most are not marked.As for the root cause of the first reoperation, i cannot conclude it with certainty.It is described as patella erosion and soft tissue reaction but i don't have any evidence except for a fairly blurry intraoperative photo.Causes of patella erosion are multifactorial.The cause could be mechanical in nature if the patella was not resurfaced.If the patella was resurfaced (or not), severe wear can occur if patella tracking is not satisfactory.Soft tissue reaction can occur as a result of impingement or polyethylene wear.The causes of stem breakage of a distal femoral replacement implant are multifactorial.They include cementing technique, surgical technique, patient factors such as bmi and activity level, and implant factors.The stem and implant would have to be examined by stryker engineers to determine the exact mode of failure.-device 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: i can confirm that these events occurred since i was able to see a preoperative x-ray, intraoperative x-rays, initial postoperative x-rays, and post-revision x-rays.This assumes that all of these documents pertain to the patient we are discussing.Most are not marked.As for the root cause of the first reoperation, i cannot conclude it with certainty.It is described as patella erosion and soft tissue reaction but i don't have any evidence except for a fairly blurry intraoperative photo.Causes of patella erosion are multifactorial.The cause could be mechanical in nature if the patella was not resurfaced.If the patella was resurfaced (or not), severe wear can occur if patella tracking is not satisfactory.Soft tissue reaction can occur as a result of impingement or polyethylene wear.The causes of stem breakage of a distal femoral replacement implant are multifactorial.They include cementing technique, surgical technique, patient factors such as bmi and activity level, and implant factors.The stem and implant would have to be examined by stryker engineers to determine the exact mode of failure.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by a surgeon that the patient had a broken implant.The primary surgery was completed on (b)(6) 2007 and the first revision surgery was completed on (b)(6) 2017.The broken implant was found one month prior to the second revision surgery.The second revision surgery was completed on (b)(6) 2022.This report is for the second revision.

• Brand Name: MRS 11MM X 127MM FEMORAL STEM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14918073
• Report Number: 0002249697-2022-00965
• Device Sequence Number: 1886363
• Product Code: KRO
• UDI-Device Identifier: 07613327048322
• UDI-Public: 07613327048322
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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 Expiration Date: 12/31/2011
• Device Model Number: 6485-3-011
• Device Catalogue Number: 64853011
• Device Lot Number: TEC320A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2006
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 80 KG