MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-62G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had right index tha (outside of cors scope on (b)(6) 2007).Patient had a right tha revision for mechanical loosening of the acetabulum on (b)(6) 2012.All components exchanged except femur.Patient has history of cancer with metastasis to pelvis, with a revision of left tha (outside of cors scope).Now the patient presents with metastasis on right femur and pelvis, undergoes revision surgery on (b)(6) 2021 with off-label components.All components exchanged.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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: trident 0° x3 insert 36mm id; cat # 623-00-36g; lot # mlmdaa.V40 cocr lfit head 36mm/+5; cat # 6260-9-236; lot # mkt4vw.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 loosening involving a trident shell was reported.The event was confirmed by medical review.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: materials reviewed:11/26/2012: stryker report.03/24/2021: stryker report.05/09/2007: op note djd right hip.Tha right.Daa approach.50mm shell, 36mm liner x3, 36)mm head delta ceramic, 3.5 femoral stem accolade.11/27/2012: op note.Revision tha right.Stem well fixed, head removed, cup loose, removed reamed to 61mm and 62mm tritanium shell placed, 36mm insert and head %mm, for accolade 1 stem.03/24/2021: op note.Secondary neoplasm, fx humerus, impending fx of right femur and pelvis.Widely metastatic carcinoma, upper and lower extremity.Increased tumor burden in femur.Significant loss of cortex.Humerus nailed with synthes nail and locked.Hip approach with hardinge, liner removed, cup felt to be fixed, defect where screw resided so cement placed.New liner 48mm mdm placed.Femur approached head removed, stem removed with a burr, large lytic area at tip of stem, crack occurred, anterior cortex completely replaced with tumor, windowed, stem out.All tumor removed as possible.Reamed, 13x300mm stem placed, 10mm calcar augment, 48 mdm head, 28mm &m inner head, cemented.Undated/unlabeled: ap and right lat hip x-rays.¿index hip¿.Stable well aligned accolade and cup.Undated/unlabeled: ap pelvis, lateral hip x-rays.Planning noted on film, cup looked loose and changed position form prior film.Undated/unlabeled: ap, lateral hip x-rays.Stem unchanged, new large acetabular component.Confirmation: a revision for a loose acetabular component may be confirmed, a revision for tumor and impending fracture was also confirmed.Root cause: the root cause of the acetabular revision cannot be ascertained without additional medical records, the revision for the impending fracture was due to metastatic cancerous lesions.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary 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
Patient had right index tha (outside of cors scope on (b)(6) 2007).Patient had a right tha revision for mechanical loosening of the acetabulum on (b)(6), 2012.All components exchanged except femur.Patient has history of cancer with metastasis to pelvis, with a revision of left tha (outside of cors scope).Now the patient presents with metastasis on right femur and pelvis, undergoes revision surgery on (b)(6), 2021 with off-label components.All components exchanged.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 62MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12809034
• Report Number: 0002249697-2021-01886
• Device Sequence Number: 20211516
• Product Code: LPH
• UDI-Device Identifier: 07613327040180
• UDI-Public: 07613327040180
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 04/30/2017
• Device Model Number: 502-03-62G
• Device Catalogue Number: 502-03-62G
• Device Lot Number: MLHLJ6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2012
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White