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

Catalog Number	0580-1-442
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the rep: "in addition to the incorrect stem that was cemented into the patient, we have found more incorrect stems (37.5/0) in the 44/2 boxes lot number: a00976.We have found another x 10 so far (11 total) all have been taken off the shelf.
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding a product mix involving an exeter stem was reported.The event was confirmed via evaluation of the box, label and part, method & results -product evaluation and results: a visual inspection was conducted on the device, label and packaging.The catalog and lot number on the box and label (0580-1-442, lot a00976) did not correspond to the catalog and lot number laser marked on the stem (0580-1-352, lot g8754849).Material analysis, functional and dimensional inspections were not performed as they were not relevant to the event.-clinician review: no medical records were received for review with a clinical consultant.-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 11 other similar events for the reported lot all related to the same issue.Conclusions: it was reported 'in addition to the incorrect stem that was cemented into the patient we have found more incorrect stems (37.5/0) in the (b)(4) boxes lot number: a00976.We have found another x (b)(4) so far ((b)(4) total) all have been taken off the shelf.' a visual inspection was conducted on the device, label and packaging.The catalog and lot number on the box and label (0580-1-442, lot a00976) did not correspond to the catalog and lot number laser marked on the stem (0580-1-352, lot g8754849).This event is deemed to be a manufacturing issue.Manufacturing nc was issued on 15 aug 2025 for this event.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23321665
• Report Number: 0002249697-2025-01114
• Device Sequence Number: 18784841
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 Catalogue Number: 0580-1-442
• Device Lot Number: A00976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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