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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: g7 pps ltd acet shell 52e item#010000663 lot#7205799, g7 dual mobility liner 42mm item#110024463 lot#980970, longevity dm bearing 28x42mm item#110030999 lot#64782759, avenir cmpl ha ho col size 6 item#574202060 lot#3080127.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the ceramic head disassociated from the stem while the patient was in the post-anesthesia care unit and had to be brought back to surgery to exchange the head.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product (from the tech eval) identified that there is no damage to the ceramic head articulating surface other than the nicks, scratches and dings on the face area.Review of the device history records as well as the ceramtec document review identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.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, 28/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 14560637
• Report Number: 0009613350-2022-00311
• Device Sequence Number: 20122933
• Product Code: LZO
• UDI-Device Identifier: 00889024430303
• UDI-Public: (01)00889024430303(17)310709(10)3077094
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/19/2022

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: 00-8775-028-03
• Device Lot Number: 3077094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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; Other
• Patient Sex: Female