MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HIGH INSIGNIA COLLARED HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	7000-6606
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of pain.Intra-operatively, the following was noted: the ceramic head was broken into at least 2 pieces.The inside of the head showed concentric wear, and the trunnion was damaged.Revising surgeon reported his assessment: the surgeon for the index procedure (different surgeon) wasted a -5 ceramic head, and implanted a +7.5 ceramic head without a sleeve.Revising surgeon believes the head was not fully impacted on the stem, leading to motion of the head on the stem.The ceramic head and neutral poly liner were revised to another ceramic head and neutral ecentric poly liner (reason for the liner change was the surgeon wanted to tighten up the construct and did not want to use a +7.5 or +10 head).
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Additional Manufacturer Narrative
Corrected data: upon further review, this device has been determined to be concomitant and there is no indication or allegation that the device reported contributed to the event.An event regarding crack/fracture of a ceramic head involving a insignia stem was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.The device was not returned; however, a photograph was provided for review.The photograph shows that the ceramic head has fractured down the midline approximately in half.Two additional smaller fragments of the ceramic head are also visible.The device fragments appear covered in blood.The damage observed on the inner taper appears consistent with motion of the head on the stem.It also appears the stem remained implanted.A full investigation is completed on the ceramic head (pr 3642784) within the same pi.No further investigation is required at this time.If additional information becomes 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 after patient complaint of pain.Intra-operatively, the following was noted: the ceramic head was broken into at least 2 pieces.The inside of the head showed concentric wear, and the trunnion was damaged.Revising surgeon reported his assessment: the surgeon for the index procedure (different surgeon) wasted a -5 ceramic head, and implanted a +7.5 ceramic head without a sleeve.Revising surgeon believes the head was not fully impacted on the stem, leading to motion of the head on the stem.The ceramic head and neutral poly liner were revised to another ceramic head and neutral ecentric poly liner (reason for the liner change was the surgeon wanted to tighten up the construct and did not want to use a +7.5 or +10 head).

• Brand Name: HIGH INSIGNIA COLLARED HIP STEM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19517457
• Report Number: 0002249697-2024-00870
• Device Sequence Number: 20341208
• Product Code: JDI
• UDI-Device Identifier: 07613327511406
• UDI-Public: 07613327511406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 7000-6606
• Device Lot Number: 99455701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 132 KG