MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX¿, HEAD, S, Ø 32/-3.5, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source¿ foreign ¿ germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent left hip revision due to the fractured head about 2 years, 4 months after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that as a result of a fall from body height, the patient underwent left hip revision due to a fractured femoral head about 2 years and 4 months after the initial surgery.During revision, the fractured femoral head was removed together with exchange of the inlay.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Patient is 64 year old at the moment of the event reported in this complaint.Radiographs were provided and reviewed from an health care professional.A pre-revision ap overview of the pelvis shows that the femoral head is no longer distributed around the stem taper but appears to be fractured into at least 2 fracture fragments.One or more fracture fragments can be seen adjacent to the stem neck.Bone quality appears normal with a small amount of lateral heterotopic ossification and no osseous fracture.The left hip acetabular abduction angle measures 45 degrees, within the normal range.No signs of loosening, wear, radiolucency, or any other contributing factor such as misalignment that would cause issues with any of the components.As reported in the documentation provided, the root cause can be attributed to the fall of the patient.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device discarded.

• Brand Name: SULOX¿, HEAD, S, Ø 32/-3.5, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16458500
• MDR Text Key: 310406524
• Report Number: 0009613350-2023-00095
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024416970
• UDI-Public: (01)00889024416970(17)300228(10)3032316
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 17.32.05
• Device Lot Number: 3032316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Prefer Not To Disclose