MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0580-1-441

Device Problem Fracture (1260)

Patient Problems Hip Fracture (2349); Ambulation Difficulties (2544)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

The following was reported: exeter stem broke.Revised with cement in cement revision stem.

Event Description

The following was reported: exeter stem broke.Revised with cement in cement revision stem.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by inspection of received device and clinician review.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar) which indicated, " the stem was returned in the fractured condition.The stem was examined with the aid of a stereo microscope at magnifications up to 50x.A material analysis was performed only on the fractured device.Damage consistent with the explantation process was observed on the anterior and posterior surfaces of the stem.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on all surfaces of the stem [1].Macroscopic surface features indicate that the fracture initiated on the lateral surface and propagated medially.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.The proximal fracture surface was examined further using a scanning electron microscope (sem).A material analysis was performed.The report concluded," the stem fractured in fatigue, with the fracture origin occurring at or near the location of the prehension hole and final fracture occurred in overload.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on all surfaces of the stem.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the stem surfaces examined.Clinician review: the available medical records were provided to the consulting clinician for a review which noted, "no clinical or pmh, no operative reports, no examination of explanted components.Based upon the information provided, the event description can be confirmed, but insufficient data is presented to create a medical report for this case." device history review: all devices 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.Conclusion: it was reported that the patient's hip was revised due to fracture of the stem.The available medical records were provided to the consulting clinician for a review which noted that no clinical or pmh, no operative reports, no examination of explanted components.Based upon the information provided, the event description can be confirmed, but insufficient data is presented to create a medical report for this case.A material analysis was performed on the returned device.The report concluded that the stem fractured in fatigue, with the fracture origin occurring at or near the location of the prehension hole and final fracture occurred in overload.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on all surfaces of the stem.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the stem surfaces examined.The root cause could not be determined as insufficient information was available.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10920299
• MDR Text Key: 218707322
• Report Number: 0002249697-2020-02564
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G7039788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 106