MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 6MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400140

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cyst(s) (1800)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Curettage bone cyst talus and mobile bearing exchange.

Manufacturer Narrative

The evaluation revealed the sliding core from the star system to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The sliding core was documented as faultless prior to distribution.During investigation no visual or manufacturing related issues were found.The sliding core was delivered and evaluated by an external lab.The provided pictures indicate no significant surface damages.The provided x-rays, patient data and surgery reports were evaluated by a health care professional: ¿on the radiographs attached after implant insertion a few things are noted that would need to be correlated to the initial pre-op radiographs.Presence of large anterior osteophyte.Tibia-fibula synostosis.Both of the above findings certainly can create significant ankle pain and not related to the implant.The statement about the cysts is questionable as i do not see any cyst formation in the talus nor the tibia".Based on the hcp evaluation the reported cyst in the talar neck could not be confirmed; furthermore the revision was not implant related.The case is attributed to the patient (osteophyte, tibia-fibula synostosis).The ifu includes heterotopic bone formation and osteolysis as adverse effects that can lead to revisions.Review of complaint history, capa databases, risk analysis and labelling did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

Curettage bone cyst talus and mobile bearing exchange.

• Brand Name: SLIDING CORE UHMPWE, 6MM
• 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: 6668525
• MDR Text Key: 78442176
• Report Number: 0008031020-2017-00382
• 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: 09/01/2017

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: 03/01/2015
• Device Catalogue Number: 400140
• Device Lot Number: 0931065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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: 66 YR
• Patient Weight: 64