MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. 46MM O.D. SIZE G BEARING; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010268 - g7 cup - 6458437.110024465 - g7 liner - 818890.00625006550 - bone screw - j6793113.00625006540 - bone screw - j6977147.71342804 - smith and nephew head - 21em01869.Unknown smith and nephew stem - unknown part and lot.Customer has indicated that the product is being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right hip revision after approximately 2 months post op due to the bearing popping off the competitors head component.The head and bearing were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent a hip revision due to dislocation.Approximately 7-8 weeks later, the patient experienced two subsequent joint dislocations.The patient then underwent a second revision surgery.During the procedure, the bearing was found to have disassociated from the head.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.The following sections were updated/corrected.Updated: a4; a5; b5; b7; d9; g2; g3; 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual review of the returned liner shows head fully seated upon return.Head is not a zimmer biomet device and is not being evaluated.Liner shows nicks, gouges, and scratches from use.Liner is not etched and lot can't be confirmed.No other damage was noted.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined, however it was noted that a competitor's head was used with the zm products and its unknown if this caused or contributed to the dislocation and disassociation of the bearing and liner.A summary of the investigation has been sent to the customer.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 additional event information to report at this time.

• Brand Name: 28MM I.D. 46MM O.D. SIZE G BEARING
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14548599
• MDR Text Key: 292981516
• Report Number: 0001822565-2022-01612
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024672713
• UDI-Public: (01)00889024672713(17)250331(10)65689634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031013
• Device Lot Number: 64689634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/06/2022; 09/08/2022
• Supplement Dates FDA Received: 06/29/2022; 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White