MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 26-0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6364-2-126

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/15/2018

Event Type  Death  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

This case is post mktg clinical trial for (b)(4).It was received the case card.It was mentioned as unk death.

Manufacturer Narrative

An event regarding death involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including device failure modes, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This case is post mktg clinical trial for obh- 43.It was received the case card.It was mentioned as unk death.

Manufacturer Narrative

After further review, this death was reported as a routine follow up for this patient's participation in a clinical study.There were no allegations of device malfunction, involvement or medical procedure pertaining to this patient's death.Requests for additional information did not result in any alleged device involvement or allegations.Due to the insufficient data provided to indicate any device involvement in this patient's experience, the devices are being deemed concomitant.If additional information is received, the aer decision will be reevaluated.An event regarding death involving a metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including device failure modes, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This case is post mktg clinical trial for (b)(4).It was received the case card.It was mentioned as unk death.

• Brand Name: V40 FEM HEAD ORTHINOX 26-0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 8066349
• MDR Text Key: 127048288
• Report Number: 0002249697-2018-03717
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540273314
• UDI-Public: 04546540273314
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Model Number: 6364-2-126
• Device Catalogue Number: 6364-2-126
• Device Lot Number: G7038464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 42 KG