MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical products: item number: 51-114150, item name: taperloc 133 type1 bm, lot #: 6451055; item number: 010000851, item name: g7 neutral e1 liner, lot #: 6260915; item number: 010000666, item name: g7 pps ltd acet shell 58g, lot #: 6342450; item number: 010001001, item name: g7 screw, lot #: 6285164.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02959.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent revision approximately one week post-implantation due to a leg length discrepancy.The femoral head and stem components were removed and replaced.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records indicate superior position of the left acetabular cup as compared to the right, consistent with patient's history of limb length discrepancy.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: 32MM MOD HEAD COCR -3MM NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8790115
• MDR Text Key: 151018992
• Report Number: 0001825034-2019-02960
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163668
• Device Lot Number: 197470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention