MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The exeter stem was implanted in 2018.X-ray demonstrates a broken exeter stem, while still implanted.The patients hip had te be revised on friday (b)(6) 2023.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The exeter stem was (b)(6) 2018.X-ray demonstrates a broken exeter stem, while still implanted.The patients hip had te be revised on friday (b)(6) 2023.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed through evaluation of the returned device.Method & results: product evaluation and results: visual inspection: the device was returned in a fractured condition.The fracture location was through the stem neck.There was significant abrasion present on the surface surrounding the fracture area.Surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.Clinician review: no medical records were received for review with a clinical consultant.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 stem fracture.The device was returned in a fractured condition.The fracture location was through the stem neck.There was significant abrasion present on the surface surrounding the fracture area.Surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17972179
• Report Number: 0002249697-2023-01227
• Device Sequence Number: 17401788
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 05/31/2023
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G7341861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 02/03/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Male