MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0204
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Revision surgery for metallosis.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis involving an abgii stem that was mated with an lfit v40 cocr 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: no medical records were received for review with a clinical consultant.-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 the patient was revised due to metallosis.The reported abgii stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision surgery for metallosis.

• Brand Name: ABGII NO4 CEMENTLESS LEFT V40
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16500635
• Report Number: 0002249697-2023-00232
• Device Sequence Number: 3354082
• Product Code: LPH
• UDI-Device Identifier: 07613327051025
• UDI-Public: 07613327051025
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 01/30/2016
• Device Model Number: 4845-0204
• Device Catalogue Number: 4845-0204
• Device Lot Number: G3041302C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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 Sex: Unknown