MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6570-0-236
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised.Patient reported hearing a pop in his hip and afterwards, the hip started squeaking.It was determined that the liner dissociated from the shell, allowing the femoral head to rub inside the shell.Intra-operatively, the surgeon could not determine with certainty if one of the screws was proud but could neither loosen nor tighten it as it was stripped, so the surgeon burred the head down to be certain.The head and the liner were revised.
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.
Additional Manufacturer Narrative
Based on the provided information, the product reported in this investigation did not contribute to the event and is therefore considered concomitant.During revision surgery, it is considered good surgical practice to always replace bearing components such as the tibial insert or hip liner including femoral head with new devices, also because service life damage or wear is not always readily visible and these components are usually modular and removal is easy and straightforward.Additionally the event states the surgeon burred the head down as he experienced difficulty tightening or loosening the stripped screw.A full investigation is carried out on the trident ii shell mfr# 0002249697-2022-01628 and liner mfr# 0002249697-2022-01626.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient reported hearing a pop in his hip and afterwards, the hip started squeaking.It was determined that the liner dissociated from the shell, allowing the femoral head to rub inside the shell.Intra-operatively, the surgeon could not determine with certainty if one of the screws was proud but could neither loosen nor tighten it as it was stripped, so the surgeon burred the head down to be certain.The head and the liner were revised.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15797096
• Report Number: 0002249697-2022-01627
• Device Sequence Number: 17341038
• Product Code: LZO
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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 Model Number: 6570-0-236
• Device Catalogue Number: 6570-0-236
• Device Lot Number: 89850301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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: 54 YR
• Patient Sex: Male