MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-58F
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Osteolysis (2377)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by patient's attorney as a result of a legal claim that on (b)(6) 2010 the patient underwent a right hip surgery and was implanted with an lfit v40 femoral head and restoration modular hip system.It is further alleged that on (b)(6) 2021 the patient underwent right total hip revision due to corrosion and adverse tissue reaction, osteolysis of the right total hip replacement and a large pseudotumor.*update on 05-may-2022: "under indications the surgeon states that the patient developed a pseudo-tumor and elevated cobalt ions.A revision was carried out.The surgeon also noted damage to the locking mechanism of the acetabular component and revision of the acetabular component was carried out.".
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and wear involving a trident shell 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 the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the failure of a revision total hip replacement after about 10 years due to elevated ion levels, corrosion and pseudotumor.I can confirm that this event took place since i was able to review the operation report and the stickers of the implants used.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of elevated ion levels, corrosion and pseudotumor and osteolysis are multifactorial.These include surgical technique factors, patient factors, and implant factors.In order to definitely confirm corrosion a metallurgical analysis should be carried out." 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 during the patient's revision surgery, damage in the form of corrosion and wear on the acetabular components was observed and the devices were explanted.A review of the provided medical records by a clinical consultant was unable to confirm the reported events due to insufficient information.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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.Device not returned.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14494761
• Report Number: 0002249697-2022-00759
• Device Sequence Number: 14990087
• Product Code: LPH
• UDI-Device Identifier: 07613327040159
• UDI-Public: 07613327040159
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 08/31/2015
• Device Model Number: 502-03-58F
• Device Catalogue Number: 502-03-58F
• Device Lot Number: MJMNL7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female