MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 09/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01066.

Event Description

It was reported patient has been indicated for revision approximately 3 years post implantation due to pain and rom flexion; however, no revision has been reported to date.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.Reported event was confirmed with medical records and radiographs provided and reviewed.Review of the available medical records identified the patient had increased pain in right groin and difficulty flexing the hip to lift his leg up the stairs.No other issues were identified.Review of radiographs identified no issues that could contribute to the reported event.Review of the device history records identified no related deviations or anomalies during manufacturing.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

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

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416112
• MDR Text Key: 138647431
• Report Number: 0001822565-2019-01065
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151505644
• Device Lot Number: 62910283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER HEAD CATALOG#00877704401 LOT#2806923; ZIMMER STEM CATALOG#65771100920 LOT#62831841; ZIMMER HEAD, CATALOG#00877704401, LOT#2806923; ZIMMER STEM, CATALOG#65771100920, LOT#62831841
• Patient Outcome(s): Other
• Patient Weight: 106