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

Catalog Number	7000-6607
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a patient that had a left primary direct anterior hip replacement on (b)(6) 2023.Over 15 months later he reported pain and limited range of motion and subsequently followed up with dr., dr.Saw on x-ray that there were what looked to be fractured pieces of the patients biolox delta v40 femoral head.The patient was then brought to surgery for a head and liner exchange revision surgery.Intraoperatively: the surgeon noticed fragmented pieces of the biolox delta v40 and the femoral head was split in half.There were some dark staining of the soft tissues and a slight metallosis appearance.The surgeon removed the femoral head, remaining ceramic pieces in the joint, as well as the liner, the stem and cup were well fixed, not damaged, and then retained.The surgeon then put a v40 to c- taper adaptor sleeve on and a new biolox c-taper femoral head." rep reported that the (consultant) surgeon would like investigation results, and that no further information will be released by the hospital or surgeon.
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.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.
Event or Problem Description
As reported: "a patient that had a left primary direct anterior hip replacement on (b)(6) 2023.Over 15 months later he reported pain and limited range of motion and subsequently followed up with dr., dr.Saw on x-ray that there were what looked to be fractured pieces of the patients biolox delta v40 femoral head.The patient was then brought to surgery for a head and liner exchange revision surgery.Intraoperatively: the surgeon noticed fragmented pieces of the biolox delta v40 and the femoral head was split in half.There were some dark staining of the soft tissues and a slight metallosis appearance.The surgeon removed the femoral head, remaining ceramic pieces in the joint, as well as the liner, the stem and cup were well fixed, not damaged, and then retained.The surgeon then put a v40 to c- taper adaptor sleeve on and a new biolox c-taper femoral head." rep reported that the (consultant) surgeon would like investigation results, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Corrected data: upon investigation, device has been deemed concomitant.An event regarding crack/fracture of a ceramic head involving a insignia stem was reported.Conclusions: 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.There were no reported allegations against the insignia stem, which remained implanted.A investigation is completed on the ceramic head and liner under the same pi.

• Brand Name: HIGH INSIGNIA COLLARED HIP STEM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21442650
• Report Number: 0002249697-2025-00225
• Device Sequence Number: 11894125
• Product Code: LPH
• UDI-Device Identifier: 07613327511451
• UDI-Public: 07613327511451
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 7000-6607
• Device Lot Number: 11012353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male