MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40(TM). FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6364-2-136
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
Event or Problem Description
It was reported that the patient's left hip was revised due to femoral pain.A stem (implanted (b)(4) 2012), head and liner (both implanted (b)(4) 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 04-april-2023: 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 14-april-2023: the office notes also alleged "underlying soft tissue damage from metallosis".
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.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis involving a metal 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: a review of the provided medical information by a clinical consultant indicated: "revision of a primary rejuvenate stem to a cemented exeter stem with pressfit acetabulum due to recurring pseudotumor is confirmed.The liner and femoral head in this hybrid construct were subsequently revised two years later.An office note from 2022 confirms that further extensive revision surgery was scheduled to be performed on this hip.No documentation of this upcoming surgery was provided.No information was provided to establish the root cause of the recurring pseudotumors and osteolysis was provided." -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 impingement and metallosis/osteolysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision 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.
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 15/january/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 04-april-2023: per office notes received dated december 20, 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 14-april-2023: the office notes also alleged "underlying soft tissue damage from metallosis.".

• Brand Name: V40(TM). FEMORAL 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16782257
• Report Number: 0002249697-2023-00401
• Device Sequence Number: 3140284
• Product Code: JDI
• UDI-Device Identifier: 07613153122005
• UDI-Public: 07613153122005
• 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: 2014
• 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): 05/25/2023

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: 07/31/2016
• Device Model Number: 6364-2-136
• Device Catalogue Number: 6364-2-136
• Device Lot Number: G3146426
• 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
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2011
• 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: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 75 KG