MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN GMRS TIBIAL BASEPLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_LIM

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/11/2021

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.Catalog numbers and lot codes of other devices listed in this report: unknown gmrs stem lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Right revision proximal tibial replacement due to loosening.

Event Description

Right revision proximal tibial replacement due to loosening.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown gmrs baseplate was reported.The event was confirmed via evaluation 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 stated the following comment: i have had the opportunity to review documentation related to 2 pi's including the product inquiry summaries, as well as multiple radiographs from august 11, 2022 including ap, and lateral views of a revision gmrs tka with proximally replacing tibial and distal femoral replacing hinge components.In addition an operative report from august 27, 2018 describing a revision surgery resection of the proximal tibia for recurrent giant cell tumor and implantation of the gmrs knee.And a clinic note from august 11, 2022 were reviewed.The x-rays show a gmrs tka with proximally replacing tibial and distal femoral replacing hinge components with cemented stem.There are subtle lucencies around the stem indicating possible early loosening.In addition, there are calcifications at the tip of the stem consistent with stress reaction.The clinic note states that the patient had initially done quite well but 2 months prior to the visit to the clinic had gone an extensive walk and subsequently developed unrelenting significant startup pain limiting her activities.Revision surgery for tibial loosening as a result of recurrent giant cell tumor in the proximal tibia is confirmed as is anterior tibial pain.There are radiographic findings consistent with stress reaction of about the tip of the cemented tibial stem as well as lucencies suggestive of possible early loosening.The root cause of this pain and possible mechanical failure cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.-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: should additional information become available i would be happy to further this assessment.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.

• Brand Name: UNKNOWN GMRS TIBIAL BASEPLATE
• Type of Device: 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 WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15442248
• MDR Text Key: 300093147
• Report Number: 0002249697-2022-01364
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

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
• 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?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/25/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female