MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
The customer reported that a patient who had been implanted with an exeter stem in 2009 during a thr has under gone a revision.The patient tripped without falling in (b)(6) 2019 and heard a snap.The patient presented to the emergency dept and the x-ray showed a fractured stem.The customer further reported that the stem had fractured at the neck.
Event or Problem Description
The customer reported that a patient who had been implanted with an exeter stem in 2009 during a thr has under gone a revision.The patient tripped without falling in (b)(6) 2019 and heard a snap.The patient presented to the emergency dept and the x-ray showed a fractured stem.The customer further reported that the stem had fractured at the neck.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by mar.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicated: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The stem was assumed to be from a right hip if information arises that states the opposite the posterior and anterior designations will switch.The stem fractured at the neck.Damage was observed on the stem, consistent with the cement-mantle breakdown process in addition to the explantation process.Macroscopic surface features indicate that the fracture initiated on the superior surface and propagated inferiorly.Post fracture abrasion obscured the distal fracture surface; no further analysis was performed.Damage consistent with contact against a heard object was observed on the superior surface of the hip stem at the location of fracture.Metal transfer markings and a wear scar was observed on the articulating surface of the ceramic head.The proximal fracture surface of the stem 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 consistent with contact against a hard object was observed on the superior surface of the stem.Metal transfer markings and a wear scar were observed on the articulating surface of the head.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: no medical records were received for review with a clinical consultant.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 the stem fractured in fatigue with the final fracture occurring in overload.The root cause was not determined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 50MM NO 1
• 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: 8629253
• Report Number: 0002249697-2019-02036
• Device Sequence Number: 2049082
• Product Code: JDI
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Expiration Date: 03/31/2014
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G2812648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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