MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or 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
Patient was implanted on the unknown side and underwent revision surgery due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that the product was implanted on (b)(6) 2019.Patient experienced a dislocation, and underwent a closed reduction on (b)(6) 2020.During the closed reduction, the active articulation insert separated from the ceramic head.A revision was then performed on (b)(6) 2020 where the active articulation bearing and head components were removed and replaced.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that the product was implanted on (b)(6) 2019.Patient experienced a dislocation, and underwent a closed reduction on (b)(6) 2020.During the closed reduction, the active articulation insert separated from the ceramic head.A revision was then performed on (b)(6) 2020 where the active articulation bearing and head components were removed and replaced.In vivo time of this device is 3 months.Warsaw complaint is registered under (b)(4) for active articulation bearing.The investigation results did identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer 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 DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9701601
• Report Number: 0009613350-2020-00061
• Device Sequence Number: 19438772
• Product Code: LZO
• UDI-Device Identifier: 00889024430280
• UDI-Public: 00889024430280
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-028-01
• Device Lot Number: 2782568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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