MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling (2091); Blood Loss (2597)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Biomet cat#ep-200150 lot885430 na act artic e1 hip brg 28x44mm, zimmer cat#00-8775-028-01 lot#2993959 na biolox delta fem head, 28mm, -3.5mm, biomet cat#110010245 lot#6569107 54 mm g7 osseo ti limited hole acetabular cup, biomet cat#110024464 lot#891800 dual mobility acetabular liner.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported a patient underwent right tha.Subsequently, patient was revised approximately 7 months later due to recurrent dislocations.During revision from dislocation, scar tissue was found on the stem.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision procedure due to recurrent dislocations.During the procedure, scar tissue was debrided from the femoral neck and head.Pseudocapsule was removed.No other findings related to the reported event were noted.Review of the device history records identified no deviations or anomalies during manufacturing related 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10650826
• Report Number: 0001822565-2020-03446
• Device Sequence Number: 16795752
• Product Code: JDI
• UDI-Device Identifier: 00889024131835
• UDI-Public: (01)00889024131835(17)270331(10)63622660
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771101110
• Device Lot Number: 63622660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 02/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 69