MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-441
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It has been reported "implant revised due to implant breakage.No trauma, sudden pain.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the stem is fractured at the neck.Additional abrasion-like damage is observed along the body of the stem.Material analysis: a material analysis was performed and indicated the following: "plastic surface damage consistent with micro-motion1 at the stem-cement interface was observed on the medial surface of the stem.This abrasion from surgical cement is indicative of cyclic stress-strain on the stem.Fatigue mode fracture propagation was seen in high magnification images consistent with those cyclic stresses.The fracture likely initiated at a lateral corner edge of the implant assist feature, then propagated medially.The stem alloy is that which was designated on the drawing.No material non-conformances, nor manufacturing defects were found on any surfaces investigated here.".-clinician review: a review of the provided medical information by a clinical consultant indicated: "i have had the opportunity to review the information.The information was quite limited and included the per, preoperative x-rays and postoperative x-rays.There is not enough information available to perform a formal review.The nature of the complaint was sudden onset of pain without inciting trauma.Pre-operative imaging demonstrates a fracture at the superolateral aspect of the stem.Postoperative imaging confirms the stem was revised to another cemented exeter stem." -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 fracture of the exeter stem.No patient trauma events were reported.Visual inspection of the returned device indicated that the stem is fractured at the neck.Additional abrasion-like damage is observed along the body of the stem.A material analysis was performed and indicated the following: "plastic surface damage consistent with micro-motion1 at the stem-cement interface was observed on the medial surface of the stem.This abrasion from surgical cement is indicative of cyclic stress-strain on the stem.Fatigue mode fracture propagation was seen in high magnification images consistent with those cyclic stresses.The fracture likely initiated at a lateral corner edge of the implant assist feature, then propagated medially.The stem alloy is that which was designated on the drawing.No material non-conformances, nor manufacturing defects were found on any surfaces investigated here." a review of the provided x-ray images also confirmed the event.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.
Event or Problem Description
It has been reported "implant revised due to implant breakage.No trauma, sudden pain.".

• Brand Name: EXETER V40 STEM 44MM 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12084212
• Report Number: 0002249697-2021-01107
• Device Sequence Number: 4250364
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 07/31/2009
• Device Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G1031518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2009
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG