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

Model Number	0580-1-352
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported that the implanted exeter stem had broken.Revision surgery was completed and the exeter was removed and replaced with a rest mod.It was further reported that the broken stem was discovered following x rays and that the initial signs of the broken stem were noticed when the patient felt a click while walking then later had difficulty ambulating and getting out of bed and required use of walker.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results -product evaluation and results: a material analysis has been performed.The report concluded: the returned stem had fractured in fatigue; with the fracture propagating inferiorly.Eds showed that the stem chemistry was consistent with an astm f1586 which is consistent the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: undated x-rays: ap pelvis, ap left hip demonstrating bilateral hybrid tha - right reduced and nominal, left reduced with displaced fracture of femoral stem at base of neck.No clinical or pmh, no operative reports, no dated serial x-rays, no examination of explanted components.Based upon the x-rays provided, confirmation of the event description is possible, but insufficient data is presented to create a medical report for this case.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of provided medical records revealed that confirmation of the event description is possible, but insufficient data is presented to create a medical report for this case.Evaluation of the returned device indicated that the report concluded: the returned stem had fractured in fatigue; with the fracture propagating inferiorly.Eds showed that the stem chemistry was consistent with an astm f1586 which is consistent the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical or patient medical history (pmh), operative reports, dated serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the implanted exeter stem had broken.Revision surgery was completed and the exeter was removed and replaced with a rest mod.It was further reported that the broken stem was discovered following x rays and that the initial signs of the broken stem were noticed when the patient felt a click while walking then later had difficulty ambulating and getting out of bed and required use of walker.

• 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: 10473522
• Report Number: 0002249697-2020-01766
• Device Sequence Number: 16745996
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Model Number: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G3170637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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 Weight: 109