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

Catalog Number 400250

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with ankle pain.Xray and ct showed cysts in the distal tibia.The talus component was pushed anterior.Operation- posterior incision to i & d the cyst in distal posterior tibia, back filled with allograft and hydroset, plated with two synthes distal tibia plates.Patient was flipped and anterior incision was made.The talus was revised by replacing and moving the component more posterior to set under the tibia.The poly was exchanged and a tal was preformed.

Manufacturer Narrative

The talar component and the sliding core were classified as primary products during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The implants were documented as faultless prior to distribution.The implants, provided to the external lab exponent, show signs of usage but no significant damages.Furthermore the surgeon stated that the implants were not damaged during revision.Thus, a manufacturing issue can be excluded.The reported cysts were confirmed via the provided x-rays and during review of the surgery notes.Cysts were already evaluated by a hcp in the statement ¿clinical results of the star ankle prosthesis, page 70, 71¿: ¿cyst formation (bone resorption) (0 ¿ 16 %) [1, 6, 9, 10, 12, 13, 15, 17, 20, 24, 27, 28, 30] 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.¿ additionally the case was evaluated by a product expert from the development department: ¿this is a known complication and risk in the scientific literature.The exact source is unknown.Researchers believe that it is due to poly wear debris and/or fluid hydraulic pressure in the joint.¿ nevertheless, osteolysis and/or other periprosthetic bone loss (like cysts) are adverse effects and may require medical or surgical intervention (therefore listed in the ifu).Conclusion: based on the evaluation a manufacturing fault was not found but a correlation between the implants and the found cysts cannot be excluded.The case represents a recurring issue for the sliding core and will be monitored and evaluated according to pms trending procedure dqi 13-004.As an additional issue it was found that the complained talar component was already expired at the time of implantation.Also pre-operative swelling was reported no infection occurred according to the customer.Most likely the talar component was re-sterilized prior to implantation.Discrepancies were detected during risk analysis review; nc#937715 was already initiated.No other non-conformity identified; no previous or actual actions are in place.

Event Description

Patient presented with ankle pain.Xray and ct showed cysts in the distal tibia.The talus component was pushed anterior.Operation- posterior incision to i & d the cyst in distal posterior tibia, back filled with allograft and hydroset, plated with two synthes distal tibia plates.Patient was flipped and anterior incision was made.The talus was revised by replacing and moving the component more posterior to set under the tibia.The poly was exchanged and a tal was preformed.

• Brand Name: TALAR COMP,SINGLE COATED US VERS XX-SMALL, RIGHT
• 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: 5038460
• MDR Text Key: 24378861
• Report Number: 0008031020-2015-00365
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016412
• UDI-Public: 00886385016412
• 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: Physician
• Type of Report: Followup
• Report Date: 08/07/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: 400250
• Device Lot Number: 021126/1584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2004
• 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: 68 YR