MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 32MM I.D. SIZE D HIGH WALL LINER; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010263 lot 65273694 g7 osseoti multihole 50mm d.Cat# 00625006530 lot j7370441 bone screw self-tapping 6.5 mm dia.30 mm length.Cat# 00625006525 lot j7348344 bone screw self-tapping 6.5 mm dia.25 mm length.Cat# 00877503202 lot 3112555 biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14.Cat# 00786401320 lot 65603489 femoral stem press-fit collarless.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 or Problem Description
It was reported that approximately two years post implantation of a left total hip arthroplasty and incision and drainage for excessive drainage and hematoma requiring joint debridement, the patient was revised due to dislocation.While the patient was in 6 inches of water bent over at waist, the left hip dislocated.The patient subsequently had a closed reduction in the emergency room.The patient had a follow up appointment three days later and given a brace.No additional information available.
Event or Problem Description
It was initially reported that the patient was revised two years post implantation of a left total hip arthroplasty; however, the patient was not revised as initially indicated.The patient had an incision and drainage for excessive drainage and hematoma requiring joint debridement.Additional information received that approximately two years post implantation of a left total hip arthroplasty, and approximately one month after a closed reduction for dislocation, the patient was getting up from a stool and fell onto the concrete on the left hip.The patient also hit an elbow and the back of head slightly.Subsequently, the patient had a second dislocation.A closed reduction was performed in the emergency room with a brace applied.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;b5;b6;b7;g3;h2;h3;h6 the following section was corrected: b5 investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3; h6.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroscopy was performed and approximately one month later, an incision and drainage was performed for hematoma and excessive drainage.Approximately two years later, while bending in 6 inches of water, the patient dislocated and was reduced in a closed reduction at the emergency room.Approximately one month later, a second dislocation occurred when the patient fell, and another closed reduction was performed.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3; b4; b5; b6; b7; d6b; g3; h2; h3; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Additional information received.It was reported that approximately 2 years post implantation of a left total hip arthroplasty, the patient was revised due to subsequent encounters of dislocation, including one while getting off of the couch.The head and liner were exchanged without complications.The cup and stem remained implanted.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6 additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: additional medical records show that the patient was having recurrent dislocations.It was ultimately decided to perform a revision approximately 6 months ago.The implants were well fixed, with the liner and head revised.No complications were noted.Root cause remains unchanged.This complaint was confirmed based on the provided medical records.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: G7 32MM I.D. SIZE D HIGH WALL LINER
• Common Device Name: PROTHESIS, 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: 19651130
• Report Number: 0001822565-2024-02202
• Device Sequence Number: 7479713
• Product Code: LPH
• UDI-Device Identifier: 00889024519268
• UDI-Public: (01)00889024519268(17)241130(10)64580191
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/15/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 20123204
• Device Lot Number: 64580191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 08/08/2024; 03/12/2025; 05/14/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/09/2024; 03/28/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White