MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, M, 28/0, 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 Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: constrained liner with constraining ring 28 mm i.D.Size jj for use with 54 mm o.D.Size jj shell; item#: 00-8758-011-28; lot#: 64395873.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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
It was reported that the patient was implanted on the right side and underwent a revision surgery due to dislocation.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient had a right hip arthroplasty on (b)(6) 2020 and underwent revision surgery on (b)(6) 2021 due to dislocation.Harm: s3 - dislocation.Hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented.X-rays: one ap image of the pelvis dated august 26 (year has been cut off) showing a bilateral hip arthroplasty has been received.No anomalies are observed.Surgical report: one surgical report (on (b)(6) 2020) predating the reported event and thus not relevant for this complaint has been received.The implantation report dated on (b)(6) 2020 has been received, whereby the operation performed was a right thr.The implanted femoral head, liner and ring were exchanged without complications.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient had a right hip arthroplasty on (b)(6) 2020 and underwent revision surgery on (b)(6) 2021 due to dislocation.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).One ap x-ray of the pelvis dated on (b)(6) (year has been cut off) showing a bilateral hip arthroplasty has been received with no anomalies noted.No further images such as prior to the revision surgery have been received.Only the implantation report was received with no complications noted.Neither the revision report, nor devices or photos of the devices were received; therefore the condition of the components is unknown.The reported event therefore cannot be confirmed.No information regarding potential contributing conditions related to the event have been provided.Possible contributing factors for a dislocation are multifactorial and could include surgical approach, head offset choice, inadequate assembling procedure, high patient activity, inadequate information during patients counseling by surgeon leading to premature failure caused by patient behavior, patient disregarding the limits of the device or joint laxity.However, based on the available information these factors cannot be further evaluated.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).

• Brand Name: BIOLOX OPTION, HEAD, M, 28/0, 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: 12680679
• Report Number: 0009613350-2021-00538
• Device Sequence Number: 4298634
• Product Code: LZO
• UDI-Device Identifier: 00889024430440
• UDI-Public: 00889024430440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 01/14/2022

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-028-02
• Device Lot Number: 3016703
• 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: 09/24/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG