MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 52 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while opening the sterile packaging, the wire mesh was protruding from shell.An alternate device was used.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Udi#: (b)(4).The event was confirmed with product received.Visual examination of the returned product identified that a single fiber metal wire was protruding from the main shell.Dhr was reviewed and no discrepancies relevant to the reported event were found.The reported issue most likely occurred during the manufacturing of the product.An internal review has been initiated to further evaluate the reported event.The initial investigation has determined that adequate controls are in place and being followed within the manufacturing process to limit the risk of a raised or loose fiber metal wire.Review of the diffusion bond furnace cycles the complaint lot was processed confirms the process parameters were met.It is inherent to the machining process that a tool might catch a wire and pull it away from the shell.The cell rework procedure states that in this case wire cutters, a burr knife, or a titanium hammer should be used to remove loose wires.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: SHELL POROUS WITH CLUSTER HOLES 52 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9622449
• MDR Text Key: 189906540
• Report Number: 0001822565-2020-00284
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00620005222
• Device Lot Number: 64217206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1