MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 50MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: 010000848-g7 neutral e1 liner 32mm d- 6731104.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02352.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 the e1 liner would not assemble with g7 acetabular shell.Eventually the products could not be implanted and surgery was discontinued.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d10; g4; h2; h3; h4; h6.Reported event was confirmed.One g7 neutral e1 liner 32mm d and one g7 osseoti multihole 50mm d was returned and evaluated.Upon visual inspection the shell has damage to the inside radius.The liner has scuffing on the outer radius with no damage to the locking feature or the scallops.The liner fit in the shell but was not impacted by the technician.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: G7 OSSEOTI MULTIHOLE 50MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10153692
• MDR Text Key: 195152759
• Report Number: 0001825034-2020-02353
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304526341
• UDI-Public: (01)00880304526341
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010263
• Device Lot Number: 6683904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other