MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM C; PROTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: 163670, 32mm mod head cocr +3mm neck, (b)(6); 51-116140, tprlc 133 mp type1 bm so 14,(b)(6); 010000701, g7 bonemaster ltd acet shl 48c, 7482911.Report source foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01829.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient was revised twelve days post op due to dislocation.Per sales rep, the version of the acetabular cup was too anteverted and the origination of the highwall liner was causing leverage making the femoral head dislocate anteriorly.Surgeon believes the origination of the cup was fine and that it was due to a non-compliant patient.The patient had a shuffle gait and did not want to follow post operative protocol, per surgeon.The stem, head, and liner were exchanged.No allegations against the stem as it was removed because the surgeon knocked the femoral head hard dislodging the stem.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures identified the head/liner/stem laying in a tub with blood on it.No other information could be obtained from the images.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: right hip arthroplasty dislocation with abnormal cup anteversion as noted.A definitive root cause cannot be determined.The event is confirmed via provided xrays.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 32MM C
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17470882
• MDR Text Key: 320511285
• Report Number: 0001825034-2023-01825
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010(17)260129(10)6956867
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000925
• Device Lot Number: 6956867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Prefer Not To Disclose