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

Model Number	6260-9-132
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding altr , fretting and abnormal ion levels involving a metal head was reported.The event was confirmed through clinician review of the provided medial records.Method & results: product evaluation and results: visual inspection, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: revision surgery for fluid collection around left tha and pseudo tumor with mildly elevated co level of 1.9 (0-0.9), and a finding fretting.A revision surgery did occur for a "pseudo tumor".There was a report of a metal reaction and trunnionosis as well as a claim that the lfit head was recalled.That said, there was prior replacement of the head which could have caused changes on the trunnion, there was no metal staining of the tissues; and the co levels were relatively low.The patient had ongoing pain in the hip that was not clearly related to the "pseudo-tumor" and there were no abnormal soft tissue changes noted.The fluid collection was noted on a ct scan and no mars mri data was obtained preoperatively.The pathology results of the tissue nor the explants were not provided for review.The claim of a recalled device would need to be confirmed via the lot numbers.Device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: revision surgery for fluid collection around left tha and pseudo tumor with mildly elevated co level of 1.9 (0-0.9), and a finding fretting.A revision surgery did occur for a "pseudo tumor".There was a report of a metal reaction and trunnionosis as well as a claim that the lfit head was recalled.That said, there was prior replacement of the head which could have caused changes on the trunnion, there was no metal staining of the tissues; and the co levels were relatively low.The patient had ongoing pain in the hip that was not clearly related to the "pseudo-tumor" and there were no abnormal soft tissue changes noted.The fluid collection was noted on a ct scan and no mars mri data was obtained preoperatively.The pathology results of the tissue nor the explants were not provided for review.The claim of a recalled device would need to be confirmed via the lot numbers.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The patient reported she had a left tha on (b)(6) 2014.The patient was revised (b)(6) 2016 due to the screws going into the tendons.The patient has been experiencing pain since surgery.The patient went to the er on (b)(6) 2021 had a ct scan and was told she had lobular fluid surrounding her left hip and was told to follow up with her physician.The patient's physician sent her for blood work which was done on (b)(6) 2021 which showed high levels of chromium.Patient was revised on (b)(6) 2021.Patient is seeking compensation.This pi is for revision 1.The patient's physician sent her for blood work which was done on (b)(6) 2021 which showed high levels of chromium.Patient was revised on (b)(6) 2021.

• Brand Name: 32MM STD 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
• MDR Report Key: 12432508
• Report Number: 0002249697-2021-01502
• Device Sequence Number: 3503919
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 01/31/2021
• Device Model Number: 6260-9-132
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 53986101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR