MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-352
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
A dr revised an exeter hip stem as it appeared to have fractured when viewed on x-ray.The patient said she was walking downstairs a few days prior to (b)(6) and she missed a step and landed heavily and felt something crack in her left leg.The surgeon removed the exeter stem and head and replaced it with a restoration modular prosthesis.The surgeon commented that the patient had a trident cup insitu with a ceramic liner.
Event or Problem Description
A dr revised an exeter hip stem as it appeared to have fractured when viewed on x-ray.The patient said she was walking downstairs a few days prior to christmas and she missed a step and landed heavily and felt something crack in her left leg.The surgeon removed the exeter stem and head and replaced it with a restoration modular prosthesis.The surgeon commented that the patient had a trident cup insitu with a ceramic liner.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by medical review.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 17 may 2019.This inspection indicated: visual analysis: the returned devices were examined with the aid of a stereomicroscope at magnifications up to 20x.The distal section of the returned hip stem is approximately 3.2 in long from tip to fracture surface.Damage consistent with explantation was observed on the distal fracture surface.This explantation damage obscured the fracture surface; no further analysis was performed on this surface.Macroscopic surface features on the proximal fracture surface indicate the fracture initiated on the lateral surface and propagated toward the medial surface.The proximal fracture surface was analyzed further using a scanning electron microscope (sem).Dimensional & functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: a material analysis has been performed.The report concluded: the stem fractured in fatigue with the final fracture occurring in overload.Damage was observed near the location of fracture origin, consistent with contact against a hard object.Eds showed the stem was consistent with an astm f1586 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided x-ray and explant photos by a clinical consultant indicated: cementation defects around the proximal exeter stem section have contributed to progressive loss of fixation around the proximal stem section contributing to an overload condition with fatigue build-up ending in a fatigue fracture after some 7-years exactly at the location of peak overload.The patient fall represented quite likely the final trigger for fracture and the patient¿s morbid obesity should also be considered a secondary factor to contribute to failure requiring revision surgery some 7-years after primary arthroplasty.Does the review identify any procedural related factors that contributed to the event? cementation defects around the proximal exeter stem section.Does the review identify any patient related factors that contributed to the event? morbid obesity (bmi>40) should be considered a secondary factor to contribute to overload.The patient fall should be considered the final trigger for device fracture in a device with already significant fatigue build-up.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.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: the investigation concluded that crack/fracture of the stem was caused by cementation defects around the proximal exeter stem section have contributed to progressive loss of fixation around the proximal stem section contributing to an overload condition with fatigue build-up ending in a fatigue fracture after some 7-years exactly at the location of peak overload.The patient fall represented quite likely the final trigger for fracture and the patient¿s morbid obesity should also be considered a secondary factor to contribute to failure requiring revision surgery some 7-years after primary arthroplasty.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8281204
• Report Number: 0002249697-2019-00330
• Device Sequence Number: 19253917
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G3302292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 150