MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS IMPLANT; KNEE IMPLANT

Catalog Number UNK_LIM

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Because of an osteo sarcoma 1987 a hmrs implant (left knee) was implanted.After several revision surgeries (exchange of the tibial component 1998, axial change(b)(6) 2007, change of the distal stem (b)(6) 2010) in (b)(6) 2016 a clicking noise was hearable.Patient has the feeling of instability.A ventral breakage of the ring at the axle clamp of the hmrs implant of the proximal tibia was observed intraoperative.

Manufacturer Narrative

An event regarding a crack/fracture involving an unknown hmrs tibial component was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and device return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Because of an osteo sarcoma 1987 a hmrs implant (left knee) was implanted.After several revision surgeries (exchange of the tibial component 1998, axial change (b)(6) 2007, change of the distal stem (b)(6) 2010) in (b)(6) 2016 a clicking noise was hearable.Patient has the feeling of instability.A ventral breakage of the ring at the axle clamp of the hmrs implant of the proximal tibia was observed intraoperative.

• Brand Name: HMRS IMPLANT
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6223632
• MDR Text Key: 63890411
• Report Number: 0002249697-2017-00061
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 60