MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-504
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Exeter stem snapped at trunnion inside patient.Noticed on x-ray after patient fell.
Event or Problem Description
Exeter stem snapped at trunnion inside patient.Noticed on x-ray after patient fell.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed by the clinician review.Method & results: -product evaluation and results: not performed as the device was not returned.Clinician review: the available medical records were provided for a review to the consulting clinician which was rejected stating, " no clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no serial x-rays.While the single x-ray appears to confirm the event description, insufficient data is presented to create a medical report for this case." -device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that the exeter stem snapped at trunnion inside patient.The available medical records were provided for a review to the consulting clinician which was rejected stating that no clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no serial x-rays.While the single x-ray appears to confirm the event description, insufficient data is presented to create a medical report for this case.The exact cause could not be determined as insufficient information was received.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not available.

• Brand Name: EXETER V40 STEM 50MM NO 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10088079
• Report Number: 0002249697-2020-00974
• Device Sequence Number: 2561193
• Product Code: LPH
• UDI-Device Identifier: 04546540153395
• UDI-Public: 04546540153395
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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 Model Number: 0580-1-504
• Device Catalogue Number: 0580-1-504
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention