MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-441
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to femoral pain.Intra-operatively, nothing was observed to be loose, broken, or worn.An exeter stem, head, adm/ mdm poly insert and mdm metal liner were revised to a restoration modular stem construct, head, adm/ mdm poly insert and mdm metal liner with cables.Rep confirmed that no further information will be released by the hospital or surgeon.Correction: a trident x3 elevated rim insert was revised instead of a adm/ mdm poly insert and mdm metal liner.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name#v40(tm).Femoral head ; cat#6364-2-236 ; lot#g3125016.Device name#trident x3 elevated rim 36mm id ; cat#643-00-36e ; lot#mmp099.Device name#simplex p with tobramycin 1 pack ; cat#6197-9-001; lot#mcu031.Device name#simplex p with tobramycin 1 pack ; cat#6197-9-001 ; lot#mcu031.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: EXETER V40 STEM 44MM NO 1
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18451127
• Report Number: 0002249697-2024-00026
• Device Sequence Number: 7780761
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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 Catalogue Number: 0580-1-441
• Device Lot Number: G3612345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG