MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERS, X-LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400264

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Pain (1994)

Event Date 07/12/2012

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.Unknown star tibial component: extra large (33mm x 45mm).With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4).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.Device will not be returned.

Event Description

Pain in distal fibula 6 month post op, treated with cam boot and airsport.Ligament instability was later observed.In addition,, fibula stress fracture was observed in 2013.Patient went under a surgery in (b)(6) 2013, during which a poly was replaced.

Manufacturer Narrative

Product inquiry stated the tibial comp, singlecoated us vers, x-large, the sliding core, uhmpwe 11mm revision and the talar comp, single coated us vers medium, right to be the subject products.No further associated products were reported.The sliding core was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.A review of the device history records for the tibial- and the talar component could not be carried out as the lot codes were unknown and could not be provided.A physical examination could not be carried out as the devices were not available.Thus, a reasonable examination and investigation was not possible.Referring to information received the patient came to the hospital on (b)(6) 2013 complaining about pain.A stress fracture of the fibula was detected.Weight bearing x-rays showed the star implants being intact and well positioned.The radiographs furthermore showed a ¿good ingrowth¿ between bone and the implants.Due to the pain and ligamentous instability the patient was revised on (b)(6) 2013.The explanted poly showed signs of wear, but was not broken, displaced or loosened.On (b)(6) 2013 a debridement and flap had been carried out in order to manage a wound dehiscence.The implants had not been removed.Pain, stress fracture and wound complications had been clinically assessed by a hcp: ¿in most cases ankle arthroplasty comes with significant pain relief.Approx.60 % ¿ 80 % of the patients are pain free or nearly pain free in the follow up, approx.20 % ¿ 30 % have moderate pain (e.G.Starting pain), but less than 10 % of the patients have remaining pain or symptomatic pain due to a malpositioning or a malfunction of the endoprosthesis or due to additional arthrosis of the adjacent joints (mostly in rheumatoid arthritis) or soft tissue affections.Treatment is depending on the particular reason for pain.¿ (1) ¿postoperative stress fractures, mostly of the medial and lateral malleoli, are rare events.Stable undisplaced fractures (fissures) usually do not require specific surgical measures, whereas unstable displaced fractures require internal fixation (mostly with interfragmentary screws or plate fixation of the lateral malleolus).Such fractures have low impact on the clinical outcome because they normally consolidate after a short period of immobilization and reduction of weight bearing.¿ (1) ¿wound complications are frequent in total ankle arthroplasty and some of them will cause additional surgical procedures up to reconstructive surgical measures such as flap surgery.Such measures have significant impact on the hospital stay, but no particular impact on the long term outcome have been reported.¿ (1) based on the available information a deficiency of the devices in question could not be verified.The exact root cause of the fibula stress fracture, the ligamentous instability and the wound dehiscence could not be determined, but is rather patient related.X-rays revealed the star implants being intact and well positioned and they furthermore showed a ¿good ingrowth¿ between bone and the implants.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Pain, bone fracture and wound complication are listed in the ifu as known adverse effects.

Event Description

Pain in distal fibula 6 month post op, treated with cam boot and airsport.Ligament instability was later observed.In addition, fibula stress fracture was observed in 2013.Patient went under a surgery in (b)(6) 2013, during which a poly was replaced.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERS, X-LARGE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5308617
• MDR Text Key: 33833095
• Report Number: 0008031020-2015-00527
• Device Sequence Number: 1
• Product Code: NTG
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400264
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• 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
• Patient Age: 76 YR
• Patient Weight: 104