MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X49MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown stem, lot #: unknown.Item #: unknown, unknown ringloc cup, lot #: unknown.Report source: (b)(6).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 that during a hip replacement surgery, a ring loc bipolar hip system size 49 was implanted.Surgeon could not get the liner to insert after several attempts.Back-up liner was used and inserted without difficulty.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

Manufacturer Narrative

(b)(4).Reported event was confirmed by visual evaluation of the sample.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A ringloc bi-polar 28x49mm, part # 11-165222 from lot 410560, was returned and evaluated against the complaint.Visual inspection found indentations around the outer radius of the liner indicating that the liner came in contact with the ring during impaction.No damage was observed to the locking groove of the liner.The ring moves freely within the locking groove with the chamfer oriented facing outward.One end of the ring is bent and scratched.No damage was observed to the locking ring of the cup.The new information does not change the outcome of the previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: RINGLOC BI-POLAR 28X49MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9883712
• MDR Text Key: 194823062
• Report Number: 0001822565-2020-01037
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304002227
• UDI-Public: 00880304002227
• Combination Product (y/n): N
• PMA/PMN Number: K833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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 Expiration Date: 07/27/2022
• Device Model Number: N/A
• Device Catalogue Number: 11-165222
• Device Lot Number: 410560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 01/28/2021
• Supplement Dates FDA Received: 06/17/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10