MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X42MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Joint Dislocation (2374)
Date of Event	07/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110010264 g7 osseoti shell 6506717; 650-1159 delta cer fem hd 2018111666; 110024463 g7 dual mobility liner 948480.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was retained by hospital per policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02943, 0001825034-2020-02944.
Event or Problem Description
It was reported patient underwent hip revision approximately nine months post implantation due to several falls resulting in dislocation.During the procedure, malposition of the cup was noted, head, liner and cup components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Radiographs were provided and reviewed by a health care professional however they were undated.One of the x-rays seems to be post implant as staple incision line is apparent and this image appears to be dislocated.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ACT ARTIC E1 HIP BRG 28X42MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10331974
• Report Number: 0001825034-2020-02942
• Device Sequence Number: 19639044
• Product Code: LPH
• UDI-Device Identifier: 00880304485044
• UDI-Public: 00880304485044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200148
• Device Lot Number: 187890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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
• Patient Weight: 58