MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-232
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional 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.Device not returned to the manufacturer.
Event or Problem 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) 2006 and was revised on (b)(6) 2021.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 or Problem 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 on (b)(6) 2006 and was revised on (b)(6) 2021.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.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level and wear (trunnionosis) involving a metal head was reported.The event was not 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 indications portion of the operative notes that the patient had a v40 cocr femoral head in place.His cobalt level was 5.5 and his chromium level was 1.4.A pre-operative mri showed no , pseudotumor, fluid collection or muscle damage.Intraoperatively once the head was removed the surgeon commented that there was "dark fouling" on the trunnion.This was removed with a wet lap sponge and the trunnion was found to be in good condition.It is confirmed that the patient underwent revision surgery.His pre-operative cobalt and chromium levels were only slightly elevated and his pre-operative mri was benign.Intraoperatively he was found to have a small amount of "dark fouling" on the trunnion.Black material on the trunnion is not an uncommon finding in revision surgery.The trunnion itself was in "good condition".Should additional information become available i would be happy to further this assessment." 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 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.A review of the provided medical information by a clinical consultant indicated: "the indications portion of the operative notes that the patient had a v40 cocr femoral head in place.His cobalt level was 5.5 and his chromium level was 1.4.A pre-operative mri showed no , pseudotumor, fluid collection or muscle damage.Intraoperatively once the head was removed the surgeon commented that there was "dark fouling" on the trunnion.This was removed with a wet lap sponge and the trunnion was found to be in good condition.It is confirmed that the patient underwent revision surgery.His pre-operative cobalt and chromium levels were only slightly elevated and his pre-operative mri was benign.Intraoperatively he was found to have a small amount of "dark fouling" on the trunnion.Black material on the trunnion is not an uncommon finding in revision surgery.The trunnion itself was in "good condition".Should additional information become available i would be happy to further this assessment." the medical records provided for review were insufficient to confirm the reported events or determine root cause.Further information such as return of the device, pathology reports, pre- and post-operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: 32MM +4 LFIT V40 HEAD
• Common Device Name: 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 NJ NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14521031
• Report Number: 0002249697-2022-00776
• Device Sequence Number: 14859919
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K010757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: 6260-9-232
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 20169101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male