MAUDE Adverse Event Report: STRYKER GMBH (MDR) SLIDING CORE UHMPWE, 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400143

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/14/2015

Event Type  Injury  

Event Description

Revision surgery due to sudden pain in the ankle joint replacement.Patient could no longer weight bear on the affected ankle.First inlay revision 2012 due to impingement.

Manufacturer Narrative

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

Manufacturer Narrative

A review of both the former local sbi capa database and the ecapa database revealed no ncr's and no actions to be in place related to the reported event for the subject product/ product family.The event did not involve a product problem indicating a nonconformity, adverse trend or unanticipated hazard.No further action is required at this time.Product surveillance will continue to monitor complaints of this type for adverse trends.As the occurrence threshold of harms is exceeded, ncr # (b)(4) was initiated.A functional test could not be carried out due to the extent of damage.A dimensional examination could not be carried out due to the extent of damage.A review of the manufacturing records for the reported sliding core, uhmpwe, 9mm (catalogue # 400143, lot code 0742003) indicated that (b)(4) devices were manufactured and accepted into final stock in november 2007 with no reported discrepancies.Deficiency in material or manufacturing was not found.The affected sliding core was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.With respect to the available medical data a medical review was not possible.It could therefore not be determined whether the star components had been implanted in alignment respectively if edge / eccentric loading had been applied on the polyethylene sliding core.Based on the above information and referring to that no deviation was found in the manufacturing documents the breakage of the polyethylene sliding core was not related to a deficiency of the device, but was most likely linked to a fatigue fracture.Fatigue fracture of the implants is listed in the ifu as an adverse effect.

Event Description

Revision surgery due to sudden pain in the ankle joint replacement.Patient could no longer weight bear on the affected ankle.First inlay revision 2012 due to impingement.It was reported that polyethylene was fractured.

• Brand Name: SLIDING CORE UHMPWE, 9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4757246
• MDR Text Key: 16462932
• Report Number: 0008031020-2015-00181
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

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: 10/31/2012
• Device Catalogue Number: 400143
• Device Lot Number: 0742003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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: 69 YR
• Patient Weight: 70