MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 53/54/55 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown stem, lot #: unknown.00500105300, shell 53 mm o.D, 64135452.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00831.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Visual examination identified that the one of the two tabs of the lock ring had seized in the locking ring groove.The seized tab is damaged and the damage is too severe for an accurate measurement or testing.The height of the undamaged tab, and the thickness of lock ring and locking ring groove are conforming to print specifications.The liner's outer diameter was not conforming to print specifications.This is most likely due to the liner being autoclaved prior to being returned for evaluation, and from attempts to insert the liner.The bi-polar shell's instructions for use - # 87-6203-900-23 rev.C june 2016 states " prior to placing the metal shell over the polyethylene liner, ensure the metal retaining ring freely rotates by moving the metal tabs.If the ring does not move, inspect it for damage.Do not use a metal shell that has a damaged locking ring.If the locking ring isn't damaged but won't rotate freely, rotate the remaining ring into the correct position with both tabs positioned approximately 2.5 mm apart in the slot window.Snap the metal shell over the liner.However, with the information provided, a definitive root cause cannot 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.

Event Description

It was reported that the inner ring on the bipolar shell was lodged into one side of the opening, which prevented it from locking onto the liner.The surgeon was unable to dislodge the locking ring and stated that it was not usable.When attempting to implant the shell, part of the inside locking ring scratched the liner.After noticing the scratches on the liner, the surgeon said he needed a different liner.There was no harm done to the patient due to this event.Attempts were made to obtain additional information; however, none was available.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 53/54/55 MM O.D. SHELLS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9316410
• MDR Text Key: 166735711
• Report Number: 0002648920-2019-00829
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 00500105328
• Device Lot Number: 64135785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Age: 90 YR