MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400141

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Patient has pain laterally and anteriorly.Cystic changes under talus.Decision was made to revise to ttc.

Manufacturer Narrative

Evaluation revealed the talar component, the tibial component and the sliding core to be the subject products.No further associated products were reported.In the case presented a female patient had been treated with star at an unknown time.In (b)(6) 2017 the patient was revised as she was having pain laterally and anteriorly.Cystic changes were found under the talus.To address this, the attending surgeon decided for an explantation, removal of the hardware and a tibio-talo-calcaneal (ttc) (fusion of the tibia, talus and calcaneal bone).A review of the device history records revealed no discrepancies.Deficiency in material or manufacturing was not found.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.The damage modes of pitting and scratching were observed on the superior surface of the received sliding core.Slight material deformations were found at the sides, which most likely were linked to bone contact.A significant damage could not be found.The tibial- as well as the talar components showed signs of use and implantation in the form of scratches.A region of adhesive transfer with abrasive wear was identified on the tibial component.Adhesive transfer with abrasive wear was also identified on the talar component.A significant damage was not found.Cyst formation / osteolyis is a known complication, which is listed in the ifu as a known adverse effect.It has been clinically assessed by a consultant hcp: ¿spontaneous bone resorption and cyst formation represents a significant problem in ankle arthroplasty.The symptoms may be mild and will not require specific surgical measures, but in many cases revision surgery with bone grafting may be required.In advanced cases cyst formation may cause a collapse of the arthroplasty requiring implant removal and ankle fusion.¿ based on the available information a deficiency of the devices in question could not be verified.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

Patient has pain laterally and anteriorly.Cystic changes under talus.Decision was made to revise to ttc.

• Brand Name: SLIDING CORE UHMPWE, 7MM
• 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: 6401195
• MDR Text Key: 69843131
• Report Number: 0008031020-2017-00129
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

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: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 400141
• Device Lot Number: 0931064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: 06/24/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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: 32