MAUDE Adverse Event Report: ZIMMER GMBH EXAFIT T4.1; MS-30 FEMORAL STEM STANDARD AND LATERAL

Catalog Number 01.06005.401

Device Problems Partial Blockage (1065); Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.X-rays were not provided for review.The surgical report of the revision surgery was provided and will be reviewed.As no lot numbers were provided for the devices, the device history records could not be reviewed.The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i.E ms-30 femoral stem) are marketed in usa, and therefore this report was filed.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that a patient was implanted an exafit stem t4.1 in 2002 (exact date unknown) on the left side.It was reported that one day (date unknown) he felt a blockage sensation in his left leg while walking.The patient was then revised on (b)(6) 2015 due to prosthetic femoral neck breakage.

Manufacturer Narrative

It was reported that a (b)(6) years old male patient was implanted an exafit stem in 2002 and experienced a femoral stem neck fracture on his left hip while walking down the street.The patient underwent a revision surgery on (b)(6) 2015 after 13 years in vivo for the replacement of the implants.No was trend identified the compatibility check was performed and showed that the product combination was approved by zimmer.Revision surgery report dated (b)(6) 2015: the broken femoral stem was removed with a portion of cement.The cup was removed from the acetabulum without bone damages.New implants were placed with good stability.Devices analysis: the exafit stem was fractured at the neck region.The fracture had a fatigue type of failure nature which was indicated by the beach marks covering the fracture surface.The fracture originated from the anterior corner of impaction hole.The rough fracture surface indicated a forced rupture.Moreover, the anchoring side of the stem showed scratches which most probably occurred during the revision surgery.The femoral head was still fixed on the exafit neck and showed numerous fine scratches in addition to the several spots of surface changes.The insert showed damages such as scratches and indentations from the revision surgery.The flat surface of the insert looked excessively damaged.The articulating surface was observed to have slight scratches.The anchoring surface of the insert appeared slightly yellowish.The inner surface of the cup seemed to be free of damages, while the rim showed slight scratches and indentations that probably occurred during the revision surgery.Outer surface of the cup showed remains of bone attachments.On the distal region of the cup polished areas could be observed.Based on the given information and the results of the investigation, we could identify a root cause for this issue: the geometry of the neck around the impaction hole led to a high stress concentration on one or both sides of the hole, resulting in a fatigue failure of the implant.Zimmer recognized this design issue and actions were taken by modifying the shape of the impaction hole.The part was produced before the design change was in place.In early (b)(6) 2003, zimmer initiated a design change including a modification of the impaction hole to allow the use of a standard instrumentation for impaction and extraction.This resulted in the introduction of a new design of the exafit stem in (b)(6) 2003.Also during the same year 2003, there was a report in (b)(6) 2003 of breakage of the exafit stem in (b)(6) 2003.The root cause of the breakage was determined to be an impaction hole which resulted in a notch effect.The design change to the exafit stem described above addressed the root cause of the reported event at hand and therefore no further corrective action is required.The part of the case at hand was produced before the design change was in place.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: EXAFIT T4.1
• Type of Device: MS-30 FEMORAL STEM STANDARD AND LATERAL
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5126880
• MDR Text Key: 27445901
• Report Number: 9613350-2015-01345
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 01.06005.401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR