MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient had a left hip revision approximately 3 years ago.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g4, h2, h3, h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip arthroplasty with several cerclage wire surrounding the femoral stem.An acetabular cup is noted on the right.Practically nondiagnostic image.Loosening cannot be confirmed from the provided image.Additional information provided does not change the root cause of the previous investigation.

Event Description

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

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10683271
• MDR Text Key: 211460236
• Report Number: 0001825034-2020-03806
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 12/29/2020
• Supplement Dates FDA Received: 11/05/2020; 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNONW LINER.; UNKNOWN HEAD.; UNKNOWN STEM.; UNKNONW LINER; UNKNOWN HEAD; UNKNOWN STEM
• Patient Outcome(s): Other
• Patient Weight: 56