MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC+ LTD HOLE FIN SHL SZ46; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 106022, locking ring, lot # 666530.Item # ep-108222, liner, lot # 274340.Item # xl-108222, liner, lot # 696150.Item # 103531, bone screw, lot # 063030.Item # 103533, bone screw, lot # 064250.Item # 163667, femoral head, lot # 824420.Item # 51-108080, femoral stem, lot # 3275307.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03932, 0001825034-2018-03933, 0001825034-2018-03935.

Event Description

It was reported that during an initial hip procedure, a cup was implanted.The surgeon was unable to get multiple liners to seat in the implanted cup.An attempt was made using an alternate locking ring, which was also unsuccessful.All acetabular components were removed and replaced with competitor product.The device malfunction caused a surgical delay of one hour.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This 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 as the necessary information to adequately investigate the reported event was not provided.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: RNGLC+ LTD HOLE FIN SHL SZ46
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7592828
• MDR Text Key: 110812560
• Report Number: 0001825034-2018-03934
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093235
• 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,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 16-104146
• Device Lot Number: 640690
• Other Device ID Number: (01) 0 0880304 59286 5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR