MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 40MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-1058 cer bioloxd option hd 40mm 2957976.650-1065 cer option type 1 tpr sleve -3 2936757.Item #: unknown; unknown stem lot #: unknown.Item #: unknown; unknown cup lot #: unknown3 product has been received by zimmer biomet and the investigation is in process.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 - 025993.

Event Description

It was reported patient underwent a hip revision approximately four months post implantation due to poly liner detachment from cup.During the procedure, the head was noted to have articulated on the metal cup, so both the head and liner components were removed and replaced.Patient experienced discomfort and restricted daily activities.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).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

(b)(4).This follow-up report is being submitted to relay additional information.Updated: a1, b4, b5, b7, d6, d10, e1, g4, h2, h6.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and sample evaluation.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One g7 hi-wall e1 liner 40mm f and one ceramic head were returned and evaluated.Upon visual inspection the liner had the locking feature worn off and also showed damage to the scallops.The inside radius has micro scratches.The returned head has scuffing that has blackened the outside radius.Medical records were reviewed and identified the following: metallosis, poly rotated anteriorly consistent with displacement of the acetabular polyethylene insert ¿ revision of acetabular head, poly, femoral head with application of autologous platelet rich coagulant.Black and soft tissue encountered consistent with metallosis.Acetabulum itself was well fixed, no wear pattern, liner exhibited wear pattern associated with malposition and inappropriate weight distribution no dimples on the background to imply screw heads were prominent and the locking rim appeared intact.Acetabulum well seated without prominence.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 HI-WALL E1 LINER 40MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10224499
• MDR Text Key: 197679634
• Report Number: 0001825034-2020-02598
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527164
• UDI-Public: 00880304527164
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• 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: 010000942
• Device Lot Number: 6592120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 76