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

Catalog Number 400256

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Tissue Damage (2104)

Event Date 02/03/2017

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.Device not returned.

Event Description

It was reported that a poly dislocated posterior.Revision scheduled on (b)(6) 2017.Sales rep reported that "the talar comp was replaced and moved more posterior & the poly was replaced with an 8mm.Activity of patient: low.Bone quality: fair.Evidence of inflammation/infection/tissue damage: no surgical site description: appeared fine.

Manufacturer Narrative

Evaluation revealed the sliding core, the tibial component and the talar component to be the subject products.No further associated products were reported.A review of the device history records revealed no discrepancies.Deficiency in material or manufacturing was not found.The affected implants were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.In the case presented a patient had been treated with star on (b)(6) 2016 due to an arthritis of the right ankle.On (b)(6) 2017, 8 weeks after the implantation, the patient had to be revised as the polyethylene component was found to be dislocated posteriorly.The sliding core was removed and replaced by an 8 mm one.The talar component was replaced as well and positioned more posteriorly.The sliding core was examined macroscopically for signs of wear, iatrogenic damage and fracture.The damage modes of pitting and scratching were observed on the superior surface.Overall the received polyethylene sliding core was found to be in a very good condition.The talar component showed signs of use and implantation in the form of scratches, but no significant damage.Potential evidence of metal-on-metal impingement was identified on the talar component.The tibial component could not be examined as it stayed implanted.As no x-rays, medical records and operation reports were available, a medical review was not possible.It could not be determined whether the implants had been placed according to the anatomical requirements.It could furthermore not be determined if the components had been implanted in the correct positions.It could also not be determined if the patient conditions were adequate for the used implant respectively if any potential adverse effects may have contributed to the dislocation experienced.Based on the available information a deficiency of the devices in question could not be verified.The exact root cause of the dislocation could not be determined.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

It was reported that a poly dislocated posterior.Revision scheduled on (b)(6) 2017.Sales rep reported that "the talar comp was replaced and moved more posterior & the poly was replaced with an 8mm.Activity of patient: low.Bone quality: fair.Evidence of inflammation/infection/tissue damage: no surgical site description: appeared fine.

• Brand Name: TALAR COMP,SINGLE COATED US VERS MEDIUM, 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: 6366751
• MDR Text Key: 68597639
• Report Number: 0008031020-2017-00092
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 400256
• Device Lot Number: 130415/0788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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: 61 YR
• Patient Weight: 111