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

Model Number	0580-1-441
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	03/27/2023
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.The following devices were also listed in this report: exeter 2.5 i m plug 12mm; cat # 09390112; lot # l5981.Simplex p with tobramycin 1 pack; cat # 6197-9-001; lot # mgt070.Simplex p with tobramycin 1 pack; cat # 6197-9-001; lot # mit082.Trident 10° x3 insert 36mm id; cat # 623-10-36f; lot # mmpnm7.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left hip was revised due to femoral pain.A stem (implanted (b)(6) 2012), head and liner (both implanted (b)(6) 2014) were revised to a restoration modular stem construct, femoral head, and adm/ mdm liner construct.Rep confirmed that no further information will be released by the hospital or surgeon.Update (b)(6) 2023 mf: per office notes received dated (b)(6) 2022: patient is exhibiting "areas of posterior proximal femoral osteolysis between the mid and upper femoral cement mantle" and an "impingement pit or cystification also noted in the superolateral aspect of [the] femoral neck." additionally, "the recent cat scan shows dramatically significant cortical bone loss or osteolysis developing around the femoral cement mantle" and the "cortex is becoming remarkably thin in some regions." update (b)(6) 2023: the office notes also alleged "underlying soft tissue damage from metallosis.".

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16797225
• Report Number: 0002249697-2023-00408
• Device Sequence Number: 3140331
• 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: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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
• Device Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G3303024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/24/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 75 KG