MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR. LINER +5 SZ 23; 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	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 11-107018 ¿ freedom head ¿ 461660, unknown cup ¿ unknown part and lot, unknown stem ¿ unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.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 - 01117.
Event or Problem Description
It was reported that patient underwent three hip revisions after approximately 15 years post initial implantation.The patient is currently experiencing recurring dislocations requiring a closed reduction.A revision is being planned; however no surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Reported event was confirmed by review medical records and radiographs noting recurring dislocations, liner wear and fracture, and metallosis.After the third revision, the patient experienced another dislocation leading to closed reduction.Another revision surgery is anticipated.X-rays show superior dislocation of the femoral head, osteopenia and moderate degenerative changes in the right hip.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A final response was requested and sent to the complainant.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: FREEDOM CONSTR. LINER +5 SZ 23
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9829945
• Report Number: 0001825034-2020-01114
• Device Sequence Number: 10948427
• Product Code: KWZ
• UDI-Device Identifier: 00880304203501
• UDI-Public: (01)00880304203501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 02/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-107022
• Device Lot Number: 773250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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: Other