MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	00-8775-032-03
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#00786401320 ;lot# unknown ;item name: femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 13 138 mm stem length cementless; item#00875705002 ;lot# unknown ;item name:50mm o.D.Size hh porous uncemented with multi-holes shell use with hh liners; item#00875100932 ;lot# unknown ;item name:32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell; item#unk trilogy screws ;lot# unknown ;item name: unk trilogy screws ; therapy date: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient experienced a fall approximately nine years post implantation on an unknown date and now is experiencing hip pain.No intervention has been reported to date.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, d4, g3, g6, h2,h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be established.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 16276249
• Report Number: 0009613350-2023-00026
• Device Sequence Number: 17890796
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: (01)00889024430334
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: Lay User/Patient
• Device Model Number: 00-8775-032-03
• Device Catalogue Number: 00-8775-032-03
• Device Lot Number: UNKNOWN
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female