MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-443
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/30/2021
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.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.Device not returned.
Event or Problem Description
The surgeon reported "an event took place in 2019: patient (b)(6), implant broke at the exeter's neck (without any notion of particular trauma)".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the event description for this pi stated: the surgeon reported "an event took place in 2019: patient 130kilos, implant broke at the exeter's neck (without any notion of particular trauma)".The operative report (b)(6) 2012 describes a standard uncomplicated procedure.The ap pelvis and lateral x-rays demonstrate a well fixed cemented femoral stem with a displaced transverse fracture through the base of the neck of the femoral prosthesis.The post revision ap pelvis x-ray shows a well fixed cemented long stem tha in anatomic position.There are cerclage wires and a transverse lucency on the lateral cortex of the femur at a level consistent with the tip of the index prosthesis providing evidence that an extended trochanteric osteotomy was performed to extract the index femoral component.Following review of this documentation fracture of the neck of an exeter femoral prosthesis and subsequent revision can be confirmed.With the limited information provided the root cause of this material failure can not be determined.-device history review: review of the device history records indicate 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 lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: the operative report (b)(6) 2012 describes a standard uncomplicated procedure.The ap pelvis and lateral x-rays demonstrate a well fixed cemented femoral stem with a displaced transverse fracture through the base of the neck of the femoral prosthesis.The post revision ap pelvis x-ray shows a well fixed cemented long stem tha in anatomic position.There are cerclage wires and a transverse lucency on the lateral cortex of the femur at a level consistent with the tip of the index prosthesis providing evidence that an extended trochanteric osteotomy was performed to extract the index femoral component.Following review of this documentation fracture of the neck of an exeter femoral prosthesis and subsequent revision can be confirmed.With the limited information provided the root cause of this material failure can not be 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.
Event or Problem Description
The surgeon reported "an event took place in 2019: patient 130kilos, implant broke at the exeter's neck (without any notion of particular trauma)".

• Brand Name: EXETER V40 STEM 44MM NO 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12518682
• Report Number: 0002249697-2021-01614
• Device Sequence Number: 5159578
• Product Code: LPH
• UDI-Device Identifier: 04546540153326
• UDI-Public: 04546540153326
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 10/11/2014
• Device Model Number: 0580-1-443
• Device Catalogue Number: 0580-1-443
• Device Lot Number: G2928434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 130 KG