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

Model Number 6260-9-136

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Patient called to report that shortly after a stryker hip was implanted in his left hip in 2009, the hip had been recalled due to elevated metal counts.Recently a physician has prescribed over-the-counter medications to reduce metal counts.

Manufacturer Narrative

It was noted that the device is not available for evaluation.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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was confirmed.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 stated the following comment: an adverse event related to a rejuvenate modular stem was noted and documented in the medical record.The metal levels appear related to the recalled modular interface.The event was confirmed.No further consultation or discussion is required.-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 abnormal ion level of the metal head was observed.A review of the provided medical records by a clinical consultant stated the following comment: an adverse event related to a rejuvenate modular stem was noted and documented in the medical record.The metal levels appear related to the recalled modular interface.The event was confirmed.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported excessive metal ion due to corrosion is considered to be under the scope of this recall.No further investigation is required.

Event Description

Patient called to report that shortly after a stryker hip was implanted in his left hip in 2009, the hip had been recalled due to elevated metal counts.Recently a physician has prescribed over-the-counter medications to reduce metal counts.Update: "rejuvenate modular neck hip stem revision.Pain, cobalt and chromium toxicity, trunnionosis.Stem, and liner exchanged." rep confirmed that the shell and screw were not revised.

• 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: 15307897
• MDR Text Key: 298775141
• Report Number: 0002249697-2022-01248
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: 6260-9-136
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MHNH8L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 82 KG