MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-136

Device Problem Degraded (1153)

Patient Problems Fall (1848); Pain (1994); Metal Related Pathology (4530)

Event Date 04/06/2023

Event Type  Injury  

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.H3 other text : not returned.

Event Description

Study subject.Under investigation for contralateral knee and upper leg pain after fall.Elevated cobalt blood levels found.

Event Description

Study subject.Under investigation for contralateral knee and upper leg pain after fall.Elevated cobalt blood levels found.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "these records confirm that the patient had a pressfit right tha that over time became painful.Serums studies demonstrated elevated cobalt levels.An mri failed to show any evidence for latr, the surgeon chose to monitor the patient carefully.I cannot discern the root cause of elevated seum cobalt levels and ongoing hip pain from the limited documentation provided." -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 is under investigation for contralateral knee and upper leg pain after fall.It was also reported that elevated cobalt blood levels found.A review of the provided medical records by a clinical consultant indicated: "these records confirm that the patient had a pressfit right tha that over time became painful.Serums studies demonstrated elevated cobalt levels.An mri failed to show any evidence for latr, the surgeon chose to monitor the patient carefully.I cannot discern the root cause of elevated seum cobalt levels and ongoing hip pain from the limited documentation provided." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 COCR LFIT HEAD 36MM/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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18109322
• MDR Text Key: 327882152
• Report Number: 0002249697-2023-01380
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MMD6RH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG