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

Catalog Number	6260-9-136
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding abnormal ion level 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.-clinician review: a review of provided medical records with a clinical consultant indicated: summary: this product inquiry concerns a male patient who underwent a left primary total hip arthroplasty with a cobalt chrome femoral head and a polyethylene lined acetabular component on july 2, 2008.He sustained trunnion failure of his right hip prior and had a revision of the hip including the stem.According to the event description and the operation report the patient had "elevated serum cobalt levels" and revision was carried out where he polyethylene liner was exchanged as well as the metal head being removed and replaced.In the operation report it states that the procedure was a revision of the femoral head to a ceramic head with a sleeve but in the bottom of the operation report there is no mention of placement of the sleeve.Following this is a pathology report that appears to be a gross examination only.There was an inscription on what appears to be the femoral head which i cannot read because a yellow marker obscured the writing.Confirmation of event: i can confirm that the patient had a revision of his left total hip arthroplasty since i was able to review the operation report of december 12, 2018.I cannot confirm the exact date of the primary procedure.I cannot confirm elevated cobalt levels because i have no supporting evidence of that.Root cause analysis: the root cause of this event cannot be determined with certainty.I have no supporting evidence that the patient had elevated cobalt levels and the operation report states there was some where particles around the head and trunnion but there is no mention of any corrosion or trunnion damage.If we assume that the patient had elevated cobalt levels, the causes are multifactorial including surgical technique in the way the femoral head and trunnion is prepared and implanted, especially cleaning and drying completely.Implant factors can also contribute.Regarding the revision, i do have concern because the surgeon stated he used a sleeve but in the body of the operation report there is no mention of using a sleeve when he converted the metal head to a ceramic head on an existing trunnion.-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: the subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of the nc and 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 march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
Event or Problem Description
The patient underwent a left tha on (b)(6) 2008, and was revised on 12/12/2018 due to alleged elevated serum cobalt levels and corrosion.

• Brand Name: V40 COCR LFIT HEAD 36MM 0 OFFSET
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19656296
• Report Number: 0002249697-2024-00946
• Device Sequence Number: 6914391
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 6260-9-136
• Device Lot Number: 87EMRD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2007
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male