MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).The reported event was identified during review of a journal article brüggemann, a., mallmin, h., & hailer, n.P.(2018).Do dual-mobility cups cemented into porous tantalum shells reduce the risk of dislocation after revision surgery?,1-8.Doi:10.1080/17453674.2018.1432927.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of the product is unknown.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: 0001822565 - 2018 - 05111, 0001822565 - 2018 - 05112, 0001822565 - 2018 - 05114.

Event Description

It was reported in a journal article that one patient underwent a re-revision due to aseptic loosening within the pe group that caused a dislocation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated: reported event was unable to be confirmed due to limited information provided.Device history record (dhr) was unable to be reviewed as the lot number was not provided.The root cause of the reported event cannot be determined with the information available.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 Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7889765
• MDR Text Key: 120736270
• Report Number: 0001822565-2018-05113
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention