MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 32 MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 163670 32mm mod head cocr +3mm neck lot#: j3832096.Report source: foreign: (b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-04421.

Event Description

It was reported that the patient underwent a revision procedure due to instability.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d8, g3, g6, h2, h3, h6, h10.The event was confirmed with radiographs received.Review of the radiographs identified the following: -bilateral total hip arthroplasties with possible oversized left acetabular cup with medial acetabular screw extending into the pelvis outside of the bone.Device history record 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

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

• Brand Name: LINER STANDARD 32 MM I.D.
• 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
• MDR Report Key: 11066682
• MDR Text Key: 223441934
• Report Number: 0002648920-2020-00540
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00630505632
• Device Lot Number: 63973192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention