MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	A00976
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been 13 other similar events for the reported lot all related to the same issue.This event is deemed to be a manufacturing issue.Manufacturing nc was issued on 15 aug 2025 for this event.This mdr is for the catalog and lot number on the box and label (0580-1-442, lot a00976), which did not correspond to the catalog and lot number laser marked on the stem (0580-1-352, lot g8754849).
Event or Problem Description
This mdr is for the stem implanted on (b)(6) 2025.When i was following up on product field action responses, a customer noted that their two stems were already implanted into patients.Both surgeons were satisfied with the outcomes of the procedures and have not reported any issues related to the size of the implants; no negative impacts noted by the patients.Date of implants were (b)(6) 2025 & (b)(6) 2025 - the pfa and communications to customers were sent on (b)(6) 2025.From the customer (lead theatre practitioner): "the exeter v40 stem was implanted on (b)(6) 2025 and again on (b)(6) 2025.I have confirmed with both surgeons that they are satisfied with the outcomes of the procedures.Furthermore, they have not reported any issues related to the size of the implants, nor have there been any negative impacts noted by the patients at this time.".

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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 ; 2018315000
• MDR Report Key: 24663114
• Report Number: 0002249697-2026-00220
• Device Sequence Number: 18463966
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A00976
• Device Catalogue Number: 0580-1-442
• Device Lot Number: A00976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PFA 4085828
• Patient Sequence Number: 1
• Patient Sex: Unknown