MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total hip arthroplasty, and approximately 9 years later medical intervention was required due to dislocation.The patient was admitted overnight for pain relief.The patient did not undergo a revision, the implants are still in place.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Medical devices: 46mm o.D.Size ff porous uncemented with cluster holes shell use with ff liners; item# 00875704601; lot# 61372515.Biolox delta ceramic taper liner, size ff / 28 i.D.For use with 46 mm o.D.Size ff shell; item# 00877500728; lot# 2515413.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset; item# 65771100900; lot# 61609829.Report source - foreign: united kingdom.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
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 and/or corrected information.Product remains implanted, therefore product evaluation could not be performed.Review of the manufacturing records identified no deviations or anomalies during manufacturing.Device used for treatment.The crf for the clinical study was provided and reviewed.Patient underwent a tha on the right side because of osteoarthritis.Patient had no issue for two years, when suffered dislocation of the right hip.Patient is treated via manipulation under anesthesia in order to reduce the dislocation, but no revision surgery was performed.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, 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: 16263202
• Report Number: 0009613350-2023-00020
• Device Sequence Number: 6066480
• Product Code: LZO
• UDI-Device Identifier: 00889024430280
• UDI-Public: (01)00889024430280(17)141031(10)2522710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 10/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00877502801
• Device Lot Number: 2522710
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2009
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 59 KG