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

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery approximately six years post right total hip arthroplasty revision due to pain and stem fracture.Wear of head and liner was noted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: unknown cocr-alumina liner; item# unknown, lot# unknown femoral stem - revision taper - nitrided cementless 17 mm diameter 185 mm stem length; item# 00998201718, lot# 62934983.G2 ¿ foreign ¿ australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned, but pictures of the explants were provided.A femoral stem fractured inside the cone body is visible.Products were shown covered in bio debris.Only one side of the head is visible and look inconspicuous.The competitor cup and liner are still assembled.No further evaluation is possible using the photographs provided and as devices were not returned, no further evaluation could be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were provided and reviewed by a health care professional.The patient underwent an initial right total hip arthroplasty thirteen years ago and competitor products were implanted.As no medical documentation was received on the initial procedure, the cause and the exact date of the implantation cannot be established.The patient underwent a first revision surgery approximately eight years ago due to a fall accident that lead to a slightly comminuted fracture of the right femur.The surgical notes for this revision report that the stem subsided and was revised; cup and liner were found to be well fixed and retained.Subsequently, due to increasing pain in the right hip, the patient underwent x-ray examination that revealed a fracture of the stem.Therefore, the patient underwent a second revision surgery two years ago.An implant retrieval report was obtained from the hospital which points out to catastrophic fatigue fracture of a modular tapered fluted titanium revision stem occurred due to a combination of gross fretting/crevice corrosion and cantilever bending forces at the proximal body/distal stem junction caused by inadequate bone support of the component.X-rays were provided and reviewed by a radiologist.Review of x-rays confirmed the reported event.The stem fracture was identified.No further evaluation is possible using the x-rays provided.It was identified that zimmer biomet devices were implanted with competitor devices.As stated in the instruction for use only authorized combinations must be used: products manufactured by zimmer biomet were not originally designed to be compatible with products from other manufacturers.There is no assurance that products from different companies may be safely used in combination with each other.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 17816371
• Report Number: 0009613350-2023-00535
• Device Sequence Number: 16754195
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)250131(10)2787769
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00877503602
• Device Lot Number: 2787769
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White