MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	02/19/2020
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
Exeter v40 stem got broken.Patient has undergone surgery on (b)(6) 2017 and stryker exeter stem got broken.Patient undergone revision surgery with stryker new exeter stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by inspection and review of the x-ray by a clinician.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 08-april-2021.This inspection indicated the returned device is shown in figures 1-4.The stem was returned in the fractured condition.The stem was examined with the aid of a stereo microscope at magnifications up to 50x.Damage consistent with the explantation process was observed on the posterior surface of the stem.The fracture surfaces of the stem are shown in figures 5 and 6.Macroscopic surface features indicate that the fracture initiated on the lateral surface and propagated medially (figures 5 and 6).Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.The distal fracture surface was examined further using a scanning electron microscope (sem).Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: a material analysis has been performed.The report concluded: the fracture morphology was consistent with a fatigue fracture.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 surfaces examined for the devices with catalog numbers provided clinician review: a review of the provided medical records by a clinical consultant stated the following comment: (b)(6) 2020 x-ray ap right hip - hybrid tha with transverse fracture of cemented stem at junction of loose proximal 1/3 and fixed cemented distal 2/3 of stem.Undated implant labels: 52 trident psl ha cup, 2 screws, 28/10 degree poly insert, exeter v40 cemented stem, 28/0 v40 femoral head.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.Based upon the x-ray provided, the event description is confirmed, but insufficient data is presented to create a medical report for this case.Based upon the x-ray provided, the event description is 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 patient was revised due to breakage of an implant.The event was confirmed by inspection and review of the x-ray by a clinician.A material analysis has been performed.The report concluded: the fracture morphology was consistent with a fatigue fracture.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 surfaces examined for the devices with catalog numbers provided.A review of the provided medical records by a clinical consultant stated the following comment: (b)(6) 2020 x-ray ap right hip - hybrid tha with transverse fracture of cemented stem at junction of loose proximal 1/3 and fixed cemented distal 2/3 of stem.Undated implant labels: 52 trident psl ha cup, 2 screws, 28/10 degree poly insert, exeter v40 cemented stem, 28/0 v40 femoral head.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.Based upon the x-ray provided, the event description is confirmed, but insufficient data is presented to create a medical report for this case.Based upon the x-ray provided, the event description is confirmed, but insufficient data is presented to create a medical report for this case.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Exeter v40 stem got broken.Pateint has undergone surgery on (b)(6) 2017 and stryker exeter stem got broken.Patient undergone revision surgery with stryker new exeter stem.

• Brand Name: EXETER V40 STEM 30MM
• 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: 10355042
• Report Number: 0002249697-2020-01578
• Device Sequence Number: 3623902
• Product Code: JDI
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 0580-1-300
• Device Catalogue Number: 0580-1-300
• Device Lot Number: G3309906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 05/13/2021
• 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: 60 YR