MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, XL, 36/+7, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: shell porous with cluster holes 62 mm o.D.; item# 00620006222; lot# 61976148.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset; item# 00771101120; lot# 61904690.Liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 62 mm o.D.Shell; item# 00631006236; lot# 63909778.Therapy date: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and experienced implant dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent an initial right tha on (b)(6) 2012.Patient was revised on (b)(6) 2020 due to in-vivo corrosion, dislocation, altr, elevated metal ion levels, and pseudotumor.Subsequently, the patient experienced a dislocation on (b)(6) 2020 and again on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right total hip arthroplasty procedure on (b)(6) 2012 due to degenerative arthritis.Zimmer biomet products were implanted without complications.The patient underwent a revision procedure on (b)(6) 2020 due to corrosion, dislocation, altr, elevated metal ions, and pseudotumor.During the revision procedure, the head and liner were replaced.The patient experienced a dislocation on (b)(6) 2020 and underwent a closed reduction.The patient dislocated again on (b)(6) 2020 and underwent another closed reduction with the placement of a knee immobilizer.X-rays did not identify any fractures.No other findings/complications related to the event were noted.Product evaluation: the product remains implanted; therefore, visual and dimensional evaluation could not be performed.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.Conclusion: it was reported that the patient underwent an initial right tha on (b)(6) 2012.Patient was revised on (b)(6) 2020 due to in-vivo corrosion, dislocation, altr, elevated metal ion levels, and pseudotumor.Subsequently, the patient experienced a dislocation on (b)(6) 2020 and again on (b)(6) 2020.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).The biolox head remains implanted.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Based on the medical records obtained, the dislocations can be confirmed.Nevertheless, due to the lack of radiographs, no assessment of the hip biomechanics could be made.Therefore, the cause of the dislocations remains unknown.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
No change to previously reported event.

• Brand Name: BIOLOX OPTION, HEAD, XL, 36/+7, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11471459
• Report Number: 0009613350-2021-00126
• Device Sequence Number: 17121808
• Product Code: LZO
• UDI-Device Identifier: 00889024430549
• UDI-Public: 00889024430549
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 00-8777-036-04
• Device Lot Number: 2946703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention