MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM LONGEVITY ELEVATED LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Entrapment of Device (1212); Unstable (1667)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 01/06/2015

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products - unknown head, shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners/ pn 00875704801/ ln 62446040, fitmore hip stem a size 5/ pn 01.00551.105/ ln 2605633.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03357, 0001822565-2017-03358.

Event Description

It was reported that patient underwent total hip procedure and was revised due to pain, swelling, instability and problems sitting following a revision.All components were removed and replaced.

Manufacturer Narrative

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.Design history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

This follow-up report is being submitted to relay additional information.Concomitant medical products: screw bone 6.5 mm dia x 25 mm catalog#: 62506525 lot#: 62444801.Continuum cluster-hole shell, 48 gg catalog#: 00875704801 lot#: 62446040.Biolox delta fem head, 32 mm, +3.5 mm catalog#: 00877503203 lot#: 2568102.Fitmore hip stem a, size 5 catalog#: 0100551105 lot#: 2605633.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 patient underwent total hip procedure and was revised due to pain, swelling, instability and problems sitting following a revision.Cup, screw, head and liner were removed and replaced.Revision operative record received indicated the revision was due to iliopsoas tendon impingement cause by anterior cup overhang.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of the revision op notes.Revision op notes provided the reason for the revision was due to iliopsoas tendon impingement from anterior cup over hang.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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: CONTINUUM LONGEVITY ELEVATED LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6583060
• MDR Text Key: 75703627
• Report Number: 0001822565-2017-03359
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 62521246
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2013
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 89