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	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Metal Related Pathology (4530)
Date of Event	01/20/2022
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.
Event or Problem Description
Left hip washout and head and liner change secondary to infection.Doctor noted signs of mechanical wear/early metalosis of the head and discolouration of the poly liner.
Event or Problem Description
Left hip washout and head and liner change secondary to infection.Doctor noted signs of mechanical wear/early metalosis of the head and discolouration of the poly liner.
Additional Manufacturer Narrative
Reported event: an event regarding infection and wear (metallosis) involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: the metal femoral head was returned assembled to the poly liner.There is a small amount of dark material evident on the inner taper of the head.There is nothing else remarkable to note.Material analysis: visual inspection noted that there is a small amount of dark material evident on the inner taper of the head.As the femoral stem was not returned, the condition of the stem taper cannot be assessed.Based on the information available, there is no indication from this that there is any material or manufacturing defect with this device and therefore no further material analysis is required.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray demonstrated bilateral tha in anatomic position without evidence of loosening or mechanical complication.The brief operative note described an i and d with liner and head exchange undertaken due to infection.Revision head and liner exchange with an i and d is confirmed." 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.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.Signs of mechanical wear/early metallosis were observed intraoperatively.Visual inspection noted that there is a small amount of dark material evident on the inner taper of the head.As the femoral stem was not returned, the condition of the stem taper cannot be assessed.Based on the information available, there is no indication from this that there is any material or manufacturing defect with this device and therefore no further material analysis is required.A review of the provided medical information by a clinical consultant did not confirm the infection or wear/metallosis events.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, the primary/revision operative reports, and 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13518842
• Report Number: 0002249697-2022-00215
• Device Sequence Number: 19929633
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 01/31/2024
• Device Model Number: 6260-9-132
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 68903105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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: 67 YR
• Patient Sex: Female