MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® OPTION, HEAD, XL, 28/+7, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right hip revision surgery (b)(6) 2019 due to instability.Subsequently patient experienced dislocation and underwent a closed reduction on (b)(6) 2019.
Additional Manufacturer Narrative
Concomitant medical product: constrained liner with constraining ring 28 mm i.D.Size ii for use with 52 mm o.D.Size ii shell catalog#: 00-8758-010-28; lot#: 64166540.The manufacturer did not receive x-rays, or other source documents for review.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).Device evaluated by manufacturer? remains implanted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: patient information: patient: (b)(6): on (b)(6) 1950, female 170 pounds.Height: 65 inches.Significant past medical history: oa.Bmi: 28.3 (overweight).Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00668.
Event or Problem Description
It was reported that the patient underwent a right hip revision surgery on (b)(6) 2019 due to instability.Subsequently patient experienced dislocation and underwent a closed reduction on (b)(6) 2019.
Additional Manufacturer Narrative
Investigation results were made available.Investigation and conclusion: 1.Event description: it was reported that the patient underwent a right hip revision surgery on (b)(6) 2019 due to instability.The patient then experienced dislocated and underwent a closed reduction on (b)(6) 2019.Harm: s3 - dislocation.Hazardous situation: unknown.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient underwent a right hip revision surgery on (b)(6) 2019 due to instability.The patient then experienced dislocated and underwent a closed reduction on (b)(6) 2019.Based on the investigation the reported event cannot be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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).
Event or Problem Description
Investigation results are now available.

• Brand Name: BIOLOX® OPTION, HEAD, XL, 28/+7, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM
• 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: 13018520
• Report Number: 0009613350-2021-00668
• Device Sequence Number: 4625321
• Product Code: LZO
• UDI-Device Identifier: 00889024430464
• UDI-Public: 00889024430464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2022

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-028-04
• Device Lot Number: 2812644
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 12/29/2021; 01/27/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/25/2022; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG