MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION HEAD SYSTEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source: us.Visual examination of the returned products identified that the ring is no longer attached.The ceramic head remained seated upon return.Liner shows nicks and scratches to all areas.Anti rotation scallops show indentation damage.Liner tabs are deformed and exhibit gouge damage.Constraining ring shows scratches from use.Metal abrasion damage is noted on the top side and the raised area from head dislocation.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.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 on (b)(6) 2015.The patient was revised on (b)(6) 2019 due to pain and recurrent dislocations.A constrained liner and ceramic head were placed.The patient was revised a second time on (b)(6) 2023 due to dislocation.A closed reduction was attempted in the emergency room, but ultimately the head and liner were revised with another constrained liner and ceramic head.Radiographs were provided and reviewed by a health care professional.Review of the available records identified a displacement of the constraining portion of the right hip arthroplasty.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.
Event or Problem Description
It was reported patient underwent right hip revision approximately 4 years post implantation due to dislocated constrained liner.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BIOLOX OPTION HEAD SYSTEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 18503125
• Report Number: 0009613350-2024-00018
• Device Sequence Number: 18179166
• Product Code: LZO
• UDI-Device Identifier: 00889024430488
• UDI-Public: (01)00889024430488(17)301031(10)3044295
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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 Model Number: N/A
• Device Catalogue Number: 00877703202
• Device Lot Number: 3044295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• 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: 08/18/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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: ACETABULAR 32 MM FOR USE WITH 58 MM SHELL; KINECTIV MODULAR NECK J2
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White