MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Model Number 400-254

Device Problems Device Slipped (1584); Osseointegration Problem (3003); Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Necrosis (1971); Pain (1994); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Remains implanted.

Event Description

The following event was reported by patient¿s wife: my husband received a star ankle replacement on (b)(6) 2012.At first everything seemed to be going well until (b)(6) 2016, when he started having pain in ankle.Made an appointment with doctor who performed the surgery and after reading x-rays he thought the apparatus shifted and he might have to replace a part.Told him to wear a boot and keep weight off of ankle and come back in six weeks.After six weeks no improvement doctor thought maybe bone under apparatus was collapsing and he might have to scrape bone to build back up.Again 6 weeks with boot and then return to see him.During that six week interval he fractured his tibia.At this appointment he mentioned that possibly it was avascular necrosis and nothing could be done except taking out apparatus and fusing the ankle.My husband told him he did not want to do a fusion.Doctor pointed out we were in "unchartered territory", as he had never had a patient experience this problem.Again 6 weeks boot and no weight.At next appointment doctor said fracture healed and the collapsed bone seemed to be regenerating itself and he said to reschedule an appointment for 6 months (which would have been (b)(6) 2018).On (b)(6) he tripped over a step and landed on his ankle.Saw doctor and after x-ray and ct scan it was diagnosed as a broken talus bone.I asked why it keeps happening and he said the bones are "impinging ¿on each other.I asked "now what" and he indicated there is no good solution.This time he said fusion and if that did not work amputation.I was not on board with any of those scenarios.

Manufacturer Narrative

Please note the corrections to d1, d4 catalog #, d4 lot #, h6 method, h6 results and h6 conclusion codes.The reported event that could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be related to the different falls and fractures that the patient suffered from.The star ankle replacement was not created to withstand falls and tenous activity level as stated in the ifu: "[.] patient education ¿ warn the patient of the surgical risks, possible adverse effects and possible operative complications that may occur with joint arthroplasty.¿ warn the patient of the limitations of artificial joint replacement devices.¿ caution the patient to protect the joint replacement from unreasonable stresses and to follow the treating physician¿s instructions.In particular, warn the patient to strictly avoid high impact activities such as running and jumping.¿ warn the patient that artificial joint replacement devices can wear out over time, and may require replacement.[.]" in these kind of cases, only the attending surgeon has the ability to decide of upcoming steps, since the caregiver is the only person who has a complete knowledge of the case, and the medical background of the patient.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

Event Description

The following event was reported by patient¿s wife: my husband received a star ankle replacement on (b)(6) 2012.At first everything seemed to be going well until (b)(6) 2016, when he started having pain in ankle.Made an appointment with doctor who performed the surgery and after reading x-rays he thought the apparatus shifted and he might have to replace a part.Told him to wear a boot and keep weight off of ankle and come back in six weeks.After six weeks no improvement doctor thought maybe bone under apparatus was collapsing and he might have to scrape bone to build back up.Again 6 weeks with boot and then return to see him.During that six week interval he fractured his tibia.At this appointment he mentioned that possibly it was avascular neucrosis and nothing could be done except taking out apparatus and fusing the ankle.My husband told him he did not want to do a fusion.Doctor pointed out we were in "unchartered territory", as he had never had a patient experience this problem.Again 6 weeks boot and no weight.At next appointment doctor said fracture healed and the collapsed bone seemed to be regenerating itself and he said to reschedule an appointment for 6 months (which would have been april of 2018).On december 13th he tripped over a step and landed on his ankle.Saw doctor and after x-ray and ct scan it was diagnosed as a broken talus bone.I asked why it keeps happening and he said the bones are "impinging ¿on each other.I asked "now what" and he indicated there is no good solution.This time he said fusion and if that did not work amputation.I was not on board with any of those scenarios.

• Brand Name: TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7238544
• MDR Text Key: 98922662
• Report Number: 0008031020-2018-00076
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016450
• UDI-Public: 00886385016450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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 Model Number: 400-254
• Device Catalogue Number: 400254
• Device Lot Number: 100429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2012
• 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
• Patient Age: 73 YR
• Patient Sex: Male