MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number N/A

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision of the hip prosthesis due to implantation of the wrong size head.The surgeon realized the head was the incorrect size when post operative x-rays were reviewed the following morning.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Associated products: item name: g7 vit e neutral lnr 32mm c, item reference: 30103203, item lot: 65596469.Item name: g7 osseoti 3 hole shell 48mm c, item reference:110010242, item lot: 65445901.Item name: femoral stem cementless collared high offset 12/14 taper size 3, item reference:(b)(4), item lot: 3053798.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The involved products were not returned for investigation, but picture of the labels were provided and assessed.All the product labels are correctly printed and visible.The manufacturing records with the respective product labels were reviewed and it was confirmed that all the product labels are correctly printed and visible.Device used for treatment.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: 00877503602 biolox delta head 12/14 36x0.30103203 g7 vit e neutral lnr 32mm c.Although this articulation combination between the families of the head and liner is approved by zimmer, the size of the two products chosen by the surgeon are not compatible.Medical records were not provided.As reported, a wrong combination of product was implanted in the patient.No deviation or abnormalities were found in the label of the involved products.The root cause of the reported issue is attributed to use error.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.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 16415591
• MDR Text Key: 309955802
• Report Number: 0009613350-2023-00074
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)321109(10)3132644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 3132644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female