MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X50MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products unknown-unk metal acetabular liner-unknown.Unknown-unknown stem-unknown.Unknown-unknown metal head-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01644.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.: product location unknown.
Event or Problem Description
It was reported the patient experienced an intra-prosthetic dislocation (ipd) during reduction of the dislocation.Subsequently the patient was revised due to the polyethylene liner dislodging the metal head.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was confirmed.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by health care professionalhcp).Impressions: abutment of the prosthetic femoral head and acetabular cup reflecting liner displacement and intra-prosthetic dislocation (ipd) as noted.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ACT ARTIC E1 HIP BRG 28X50MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9967100
• Report Number: 0001825034-2020-01641
• Device Sequence Number: 16714933
• Product Code: LPH
• UDI-Device Identifier: 00880304485082
• UDI-Public: (01)00880304485082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 08/14/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-200156
• Device Lot Number: 730420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention