MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH HDP ASSEMBLY PACK; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
''the customer service received a call from a woman who has already been operated on twice and whose knee is apparently turned 35% outwards.She said she has suffered serious damage'' there is no further information available.
Additional Manufacturer Narrative
Corrected data: product code, common device name, manufacturing site for devices.An event regarding patient factors involving a mrh assembly pack (bushings, sleeve, bumper) was reported.The event was not confirmed.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: confirmation of event: i can confirm that the patient underwent implantation of a gmrs prosthesis with subsequent revision of the implant to correct a rotational deformity and instability since i was able to review the operation report.I can also confirm the other related operations mentioned above since i was able to review those operation reports as well.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of rotational deformity and instability of a gmrs implant are multifactorial.In this case trauma may well have played a role since the patient had a fall prior to revision surgery.Surgical technique factors contribute including the method of insertion and the final positioning, alignment and fixation.Patient factors including lifestyle, activity level and bmi can also play a role and in this case the patient did have a fall.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock on with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: confirmation of event: i can confirm that the patient underwent implantation of a gmrs prosthesis with subsequent revision of the implant to correct a rotational deformity and instability since i was able to review the operation report.I can also confirm the other related operations mentioned above since i was able to review those operation reports as well.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of rotational deformity and instability of a gmrs implant are multifactorial.In this case trauma may well have played a role since the patient had a fall prior to revision surgery.Surgical technique factors contribute including the method of insertion and the final positioning, alignment and fixation.Patient factors including lifestyle, activity level and bmi can also play a role and in this case the patient did have a fall.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: MRH HDP ASSEMBLY PACK
• 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 NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23059312
• Report Number: 0002249697-2025-00980
• Device Sequence Number: 8766171
• Product Code: KRO
• UDI-Device Identifier: 07613327045291
• UDI-Public: 07613327045291
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 10/31/2025
• Device Catalogue Number: 64812150
• Device Lot Number: LKH871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female