MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 66 MM O.D. SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 00620206620 shell porous with multi holes 66 mm lot#: 63660618.Catalog#: 00630506640 liner standard 3.5 mm offset 40 mm i.D.Lot#: 64147155.Foreign report source: (b)(6).The event was confirmed with product received.Visual inspection identified indentations to the outer surface near the scallops below the lock ring groove.Witness marks indicating impaction attempts were observed.No other damage was noted.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Event Description

It was reported that the surgeon struggled to seat 40mm liner.He attempted to seat the 36mm liner and also had difficulty.He finally was able to seat the 40mm liner.No further event information available at the time of this report.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 66 MM O.D. SHELL
• 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: 9866456
• MDR Text Key: 190789738
• Report Number: 0002648920-2020-00187
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00630506636
• Device Lot Number: 63098311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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