MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah EXETER V40 STEM 37.5MM NO 1; prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Catalog Number	0580-1-371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the trial reduction, whilst planning to use the accolade ii with bha, a screw became lodged, so we had to switch to the exeter at short notice.Once the intended size had been determined and the flag inserted, cement was mixed using 80g acm and placed into the medullary canal; however, the cement set whilst the exeter was being inserted.The exeter was subsequently removed, but it had fractured from the proximal end down to the shaft, so the wound was closed as is on this occasion.As this was an emergency procedure, the cement had not been cooled; it was mixed for one minute and inserted five minutes later.

• Brand Name: EXETER V40 STEM 37.5MM NO 1
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50160579
• Report Number: 0002249697-2026-00676
• Device Sequence Number: 15729066
• Product Code: LPH
• UDI-Device Identifier: 04546540153258
• UDI-Public: 04546540153258
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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 Catalogue Number: 0580-1-371
• Device Lot Number: A07000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female