MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-236

Device Problems Corroded (1131); Degraded (1153); Material Erosion (1214)

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

Event Date 02/07/2022

Event Type  Injury  

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.Not available.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2015 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6), 2015 and was revised on (b)(6), 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

An event regarding abnormal ion levels, corrosion and wear (trunnionosis) involving a metal head was reported.The events were confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: "the implant sheet confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at 3.6 and 0.8 respectively.A pre-operative mri showed a fluid collection and particulate debris.These mri findings were corroborated at the time of surgery.Upon removal of the femoral head some "fouling " was noted on the trunnion.He stated further that this fouling was easily wiped away with a wet sponge and the trunnion was "intact" the patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis.The indications section of the operative record reports minimal pre-operative serum metallic ion elevations and a pre-operative mri showed fluid with particulate debris, in the operative report the surgeon describes this fluid and debris as "like wet cat food".With this limited information the root cause of this issue cannot be determined." -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: a review of the provided medical information by a clinical consultant indicated: "the implant sheet confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at 3.6 and 0.8 respectively.A pre-operative mri showed a fluid collection and particulate debris.These mri findings were corroborated at the time of surgery.Upon removal of the femoral head some "fouling " was noted on the trunnion.He stated further that this fouling was easily wiped away with a wet sponge and the trunnion was "intact" the patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis.The indications section of the operative record reports minimal pre-operative serum metallic ion elevations and a pre-operative mri showed fluid with particulate debris, in the operative report the surgeon describes this fluid and debris as "like wet cat food".With this limited information the root cause of this issue cannot be determined." 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/+5
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14520824
• MDR Text Key: 292790856
• Report Number: 0002249697-2022-00773
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: L08VVT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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 Sex: Male