MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10 NARRATIVE; PROSTHESIS HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 16 16 mm distal dia.160 mm length.(b)(4).Concomitant medical products: item# 00877502801 biolox⮠delta, ceramic femoral head, s, 㸠28/-3.5, taper 12/14 lot# 2944874.Item# 14-107017 frdm cnstr hd 36mm t12/14 -3mm lot# 182610.Item# 14-107018 frdm cnstr hd 36mm t12/14 std lot# 112320.Item# 010000984 g7 freedom const e1 lnr 36mm f lot# 3266331.Item# 110010245 g7 osseoti 4 hole shell 54mm f lot# 6336052.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that taper on the stem would not engage with the femoral head.Due to this issue the liner was removed, and a different liner was implanted.Delay of procedure: 60 minutes.Attempts to obtain additional information was made; however, none was available.

Manufacturer Narrative

Reported event was confirmed by review of returned heads which indicate biomet heads were used with zimmer stem.Biomet head is not compatible with zimmer stem.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to intentional off-label, unapproved, or contraindicated use-user error.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: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8137446
• MDR Text Key: 129463273
• Report Number: 0001822565-2018-06638
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00784301606
• Device Lot Number: 77005813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other