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

Catalog Number 400257

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 05/26/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.

Event Description

Patient was having pain on medial malleolus side of her ankle.Imaging revealed a cyst in the medial malleous.Surgery was performed to remove cyst.Medication was prescribed.During the surgery, the surgeon noted no observation for all star components.2 weeks after the surgery, the patient reported of having spontaneous pain about the medial malleolus on the posterior side.

Manufacturer Narrative

All implants 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 study records included that a bone cyst was detected after ~9 years in the medial malleolus.After approx.One year tenderness over the tibial tendon behind the medial malleolus was detected; the study records does not include information that reports pain in the medial malleolus after two weeks from the revision surgery; therefore, this part of the event description cannot be confirmed.Because no further information about the tenderness was included in the study records the root cause could not be determined.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 cysts were 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); furthermore pain, are adverse effects and may require medical or surgical intervention (therefore listed in the ifu).Conclusion: based on the evaluation a manufacturing issue was not found but a correlation between the implant and the cyst cannot be excluded.The case represents a recurring issue for the sliding core and tibial component and will be monitored and evaluated according to pms trending procedure (b)(4).No non-conformity was detected.Device was revised but not returned for investigation.

Event Description

Patient was having pain on medial malleolus side of her ankle.Imaging revealed a cyst in the medial malleous.Surgery was performed to remove cyst.Medication was prescribed.During the surgery, the surgeon noted no observation for all star components.2 weeks after the surgery, the patient reported of having spontaneous pain about the medial malleolus on the posterior side.

• Brand Name: TALAR COMP,SINGLE COATED US VERS MEDIUM, LEFT
• 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: 5377662
• MDR Text Key: 36327416
• Report Number: 0008031020-2016-00026
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2006
• Device Catalogue Number: 400257
• Device Lot Number: 000213/1721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2001
• 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: 75 YR
• Patient Weight: 95