MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 4 LEFT; HIP IMPLANT

Catalog Number 5353-0-104

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

On (b)(6) 2015 primary surgery was performed.After that, a surgeon noticed a crack on the slot of the centpillar tmzf stem on the x-ray.

Manufacturer Narrative

An event regarding crack/fracture involving a centpillar stem was reported.The event was confirmed.Medical records received and evaluation: a review of the provided information by a clinical consultant reported that : at some 1-year post surgery a fracture was observed on x-ray of the lateral slotted stem tip section of the centpillar stem.The local conditions suggest this is a fatigue type of device fracture as caused by overload in the distal stem tip section.Principal contributing factor is undersizing of the stem as evident by the large space around the stem body in the femoral canal on the first post arthroplasty x-ray.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a review of the provided information by a clinical consultant concluded that: undersizing of the centpillar stem in the femoral canal during arthroplasty has caused rapid migration of the stem into varus position whereupon an overload condition developed around the stem tip through lack of proximal bone ingrown fixation and load sharing in the slotted distal stem tip section contributing to local fatigue accumulation and ending in a fatigue fracture of the lateral slot tip after 1-year.No revision is required thus far.If additional information becomes available, this investigation will be reopened.

Event Description

On (b)(6) 2015 primary surgery was performed.After that, a surgeon noticed a crack on the slot of the centpillar tmzf stem on the x-ray.

• Brand Name: CENTPILLAR TMZF SIZE 4 LEFT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5512672
• MDR Text Key: 40955098
• Report Number: 0002249697-2016-00936
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 5353-0-104
• Device Lot Number: 47549601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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): Other
• Patient Age: 69 YR
• Patient Weight: 56