MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE METS TKR - FEMORAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Injury (2348)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.

Event Description

A patient specific implant prescription form was received for patient's impending revision with diagnosis "loosening".

Manufacturer Narrative

Reported event: an event regarding loosening involving a tkr smiles femoral stem was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no item were returned.Clinician review: a review of the provided x-rays by clinical consultant indicated: "implant in situ was for a mets tkr, the date of insertion was unknown.The surgeon now reported loosening of the implant.The x ray provided showed the radiolucent lines along the femoral stem between the cement mantle and the bone.There is some resorption on the femoral cortical bone.The tibia stem also shows some radiolucent lines but in the lesser scale.Therefore, the radiographic assessment can confirm the reason for revision." product history review: review of the product history records could not be performed as no device details were provided.Complaint history review: a complaint history review could not be performed as no device details were provided.Conclusions: an event regarding loosening involving a tkr smiles femoral stem was reported.The exact cause of the event could not be determined because further information such as device identification, analysis of the retrieved implant and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.H3 other text: device not returned.

Event Description

A patient specific implant prescription form was received for patient's impending revision with diagnosis "loosening".Update 23aug2019 - a review of the provided x-rays by clinical consultant indicated: "[.] the tibia stem also shows some radiolucent lines but in the lesser scale.".

• Brand Name: METS TKR - FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 8711506
• MDR Text Key: 148402362
• Report Number: 3004105610-2019-00074
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K120992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: Lay User/Patient
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR