MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-028
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Metal Related Pathology (4530)
Date of Event	06/13/2018
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.
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 her right hip on or about (b)(6) 2013 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her 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 her right hip on or about (b)(6) 2013 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: 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.Clinical review - a review of medical records with clinical consultant indicated "conclusion/assessment: the patient underwent bilateral tha with similar components for avn with concomitant djd.No pre-operative notes, postoperative notes, radiographs or laboratory studies were provided for review.The patient then underwent a revision tha on the right side for pain.She was found to have increased cobalt levels (by operative report only, no laboratory report or values provided for review).No component loosening was noted.No corrosion or fretting was noted at the trunnion.Some corrosion was noted at the liner-cup interface but a description of the corrosion finding was not provided.The patient had an event intraoperatively and was ultimately transferred to the icu.The outcome of the resuscitation and the revision surgery were not provided for review.Event confirmation: a revision surgery was performed on the right hip and was confirmed.Injury, device recall and/or increased metal levels cannot be confirmed (increased co was stated in the operative note but values not provided).Root cause: the root cause of the revision surgery was increasing pain.The root cause for the other allegations cannot be stated as they cannot be confirmed." product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records with clinical consultant indicated "conclusion/assessment: the patient underwent bilateral tha with similar components for avn with concomitant djd.No pre-operative notes, postoperative notes, radiographs or laboratory studies were provided for review.The patient then underwent a revision tha on the right side for pain.She was found to have increased cobalt levels (by operative report only, no laboratory report or values provided for review).No component loosening was noted.No corrosion or fretting was noted at the trunnion.Some corrosion was noted at the liner-cup interface but a description of the corrosion finding was not provided.The patient had an event intraoperatively and was ultimately transferred to the icu.The outcome of the resuscitation and the revision surgery were not provided for review.Event confirmation: a revision surgery was performed on the right hip and was confirmed.Injury, device recall and/or increased metal levels cannot be confirmed (increased co was stated in the operative note but values not provided).Root cause: the root cause of the revision surgery was increasing pain.The root cause for the other allegations cannot be stated as they cannot be confirmed." 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: 28MM -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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8557777
• Report Number: 0002249697-2019-01740
• Device Sequence Number: 2935176
• Product Code: JDI
• UDI-Device Identifier: 07613327012996
• UDI-Public: 07613327012996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 11/30/2016
• Device Catalogue Number: 6260-9-028
• Device Lot Number: 38392303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2011
• 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 Age: 53 YR
• Patient Sex: Female