MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Use of Device Problem (1670)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a revision surgery of hip replacement, the surgeon encountered difficulties with the installation of the joint between the head and the liner.Indeed, the two items slide apart very easily.The surgeon elected to immediately revise the liner and head.These items were explanted.The surgery took around 25 minutes longer than expected due to the need to revise the implanted head and liner.
Additional Manufacturer Narrative
Concomitant medical products: avan e1 insert 28 s 60; catalog#: p0561e60; lot#: 0001480321.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Investigation completed, see h10.
Additional Manufacturer Narrative
Investigation results were made available.Product was not returned or pictures not provided.Visual and dimensional evaluations could not be performed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.This device is used for treatment.The products involved in the complaint are not compatible.Indeed, the birmingham cup (manufactured by smith and nephew) implanted is not compatible with the avantage insert / biolox delta ceramic head used.The ifu d011500245 ed.2016/05 for ceramic heads describes the following: due to the acquisition of pre-existing product lines, zimmer has initiated a testing program to evaluate the compatibility of these devices with implants and components made or distributed by all zimmer orthopaedic companies, which include zimmer gmbh (previously centerpulse orthopedics ltd.), zimmer, inc., zimmer trabecular metal technology, inc.(previously implex corp.), zimmer uk ltd., zimmer austin, inc.(previously centerpulse orthopedics, in c.) and biomet orthopaedic companies.Only authorized combinations must be used.Complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part/lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Reported event is not related to medical condition.Review of medical record is not applicable.Not compatible product combination might be a potential root cause for the reported event.However, a definitive root cause cannot be determined.No further actions have been initiated as a result of the reported event investigation.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• 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: 13665525
• Report Number: 0009613350-2022-00123
• Device Sequence Number: 12141547
• Product Code: LZO
• UDI-Device Identifier: 00889024430303
• UDI-Public: 00889024430303
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-028-03
• Device Lot Number: 2895208
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 98 KG