MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-128
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unequal Limb Length (4534); Insufficient Information (4580)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's hip was revised.As reported: "leg length discrepancy." a stem, head, and liner were revised.Right side.
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.
Event or Problem Description
It was reported that the patient's hip was revised.As reported: "leg length discrepancy." a stem, head, and liner were revised.Right side.
Additional Manufacturer Narrative
Reported event: an event regarding limb length discrepancy involving a ceramic head was reported.The event was confirmed through clinician review of the provided medical records.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 records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to including the product inquiry summary and 2 ap pelvis x-rays with a pressfit right tha the event description from the product inquiry summary states: it was reported that the patient's hip was revised.As reported: "leg length discrepancy." a stem, head, and liner were revised.The two ap pelvis x-rays both show a right tha with right lower extremity being significantly longer than the contralateral side.It is confirmed that the patient had a significant leg length discrepancy following a right tha no documentation was provided to verify revision surgery.The root cause of this issue is related to high femoral neck resection and placement of the stem in an elevated position.The center of rotation of the femoral head should coincide with the tip of the greater trochanter.The x-rays demonstrate the head center in this case to be well above this reference point.Should additional information become available i would be happy to further this assessment.-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 is experiencing a leg discrepancy.A review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to including the product inquiry summary and 2 ap pelvis x-rays with a pressfit right tha the event description from the product inquiry summary states: it was reported that the patient's hip was revised.As reported: "leg length discrepancy." a stem, head, and liner were revised.The two ap pelvis x-rays both show a right tha with right lower extremity being significantly longer than the contralateral side.It is confirmed that the patient had a significant leg length discrepancy following a right tha no documentation was provided to verify revision surgery.The root cause of this issue is related to high femoral neck resection and placement of the stem in an elevated position.The center of rotation of the femoral head should coincide with the tip of the greater trochanter.The x-rays demonstrate the head center n this case to be well above this reference point.Should additional information become available i would be happy to further this assessment.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.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/0
• 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: 14881863
• Report Number: 0002249697-2022-00956
• Device Sequence Number: 5162784
• Product Code: JDI
• UDI-Device Identifier: 04546540608499
• UDI-Public: 04546540608499
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 04/30/2026
• Device Model Number: 6570-0-128
• Device Catalogue Number: 6570-0-128
• Device Lot Number: 93616505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 72 KG