MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM MOD HD STD NECK TP1 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporting source- (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03094, 0001825034-2019-03097.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a revision surgery, the head would not assemble with the mating taper, a second head was used which did not work either.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

The reported head was returned and evaluated against the complaint.Visual inspection found the outer radius of the head to lightly scratched.The outer radius also exhibits a residue from an unknown dried liquid.The neck taper is free of damage and debris.Complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The root cause of the reported issue is attributed to off-label usage; there is no documentation that says that the stageone select hip stem is compatible with items other than the other components in the stageone select hip system, specifically for this case, the neck length adapters: 431186, 431187, & 431188.Specifically for this case because there are stageone select hip heads that go on top of the neck length adapters, but the hip heads are not intended to mate directly with the hip stem, but the stem, head, and neck length adapters are all part of the stageone select hip system.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: 28MM MOD HD STD NECK TP1 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8805529
• MDR Text Key: 151569361
• Report Number: 0001825034-2019-03095
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163662
• Device Lot Number: J6349237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1