MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item # 00785001400, femoral stem cemented std.Collar 12/14 neck taper std.Neck offset size 14 135 mm stem length, lot # 65299522.Item # 00785901100, distal centralizer 11 mm o.D., lot # 65337319.Item # 30103605, g7 vit e neutral lnr 36mm e, lot # 65312576.Item # 00625006525, bone screw self-tapping 6.5 mm dia.25 mm length, lot # j7249809.Item # 00625006540, bone screw self-tapping 6.5 mm dia.40 mm length, lot # j7219891.Item # unknown, unknown cement, lot # unknown.Item # 010000663, g7 pps ltd acet shell 52e, lot # 7216453.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 or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient is experiencing pain, swelling, burning sensation and has a nickel allergy.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.Complaint investigation this complaint is processed as a limited investigation.Limited investigations do not need to have the dhr, raw material certificate, sterilization certificate, complaint history, product hold/field action pulled and reviewed.Also, a review of the risk management file has not been completed as the product is considered unrelated to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Patient reported via telephone that she is experiencing swelling from her hip to foot.Doctor placed patient on prednisone which did not help the swelling.Patient states her hip is irritated with a burning groin pain and no other problems with the hip.Patient had a allergy test performed and a positive reaction to nickel and palladium.Based on the available information, the reported event can be confirmed.However, no problem was found with the biolox delta ceramic femoral head.The composition of the femoral head does not contain the reported allergens (nickel) the patient is experiencing.The only device with nickel is the femoral stem.Therefore, a limited investigation was performed and no issue with the device involved in this complaint can be found.If any further information is found which would change or alter any conclusions or information, a supplemental 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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER 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: 21265053
• Report Number: 0009613350-2025-00037
• Device Sequence Number: 13148082
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)320406(10)3111383
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: Lay User/Patient
• Device Catalogue Number: 00877503602
• Device Lot Number: 3111383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female