MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-351
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/17/2022
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.Device not returned.
Event or Problem Description
Revision was planned due to pain in the femoral diaphysis.X-ray showed stem fracture.Patient was not very much active, but loosening was found in the proximal part.Mismatch with the adherent distal part might cause stem fracture.
Event or Problem Description
Revision was planned due to pain in the femoral diaphysis.X-ray showed stem fracture.Patient was not very much active, but loosening was found in the proximal part.Mismatch with the adherent distal part might cause stem fracture.
Additional Manufacturer Narrative
An event regarding crack/fracture and loosening involving a exeter stem was reported.The crack/fracture event was confirmed via evaluation of the returned device and review of the provided medical records by a clinical consultant.Loosening was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device confirms that the device was fractured.The damage is consistent with fatigue accumulation in the stem ultimately ending in a fatigue fracture of the stem requiring revision.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a case of a patient who underwent a cemented bipolar arthroplasty and then about seven years later required revision for femoral stem fracture.I can confirm that this event occurred since i was able to see an x-ray, albeit unmarked, showing a left femoral hip stem fracture.The summary provided stated that the patient had explantation but no operation report or photographs of the explanted prosthesis are provided.The causes of femoral stem fracture are multifactorial, including surgical technique factors, especially cementing technique, patient factors including bmi and activity level, and implant factors." -product 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.Conclusions: it was reported that the patient was revised due to loosening and fracture of the exeter stem.Visual inspection of the returned device confirms that the device was fractured.The damage is consistent with fatigue accumulation in the stem ultimately ending in a fatigue fracture of the stem requiring revision.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a case of a patient who underwent a cemented bipolar arthroplasty and then about seven years later required revision for femoral stem fracture.I can confirm that this event occurred since i was able to see an x-ray, albeit unmarked, showing a left femoral hip stem fracture.[.] the causes of femoral stem fracture are multifactorial, including surgical technique factors, especially cementing technique, patient factors including bmi and activity level, and implant factors." 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.

• Brand Name: EXETER V40 STEM 35.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13767289
• Report Number: 0002249697-2022-00396
• Device Sequence Number: 12014040
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 12/31/2019
• Device Model Number: 0580-1-351
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G5594159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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 Sex: Female