MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BEARING; PROTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown g7 dual mobility cup.G2: foreign: united kingdom.The reported event was identified during review of a journal article.Aldridge, william., braimah, fatima., ahmed, hamida., jehan, shah., jones, simon., & ng, aaron.2023.An evaluation of outcomes in the use of g7 dual mobility cup for primary total hip replacement: a single centre retrospective study.Multiple mdr reports were filed for this event, please see associated reports: 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 in a journal abstract within a four-year period; 177 patients received a g7 dmc for a primary hip arthroplasty.Patient demographics, dislocation rate, oxford hip score (ohs), short- and long-term complications and revision surgery were all factors considered during patient assessment.Among the 177 patients, 57 patients (32%) were considered low risk for dislocation, 53 (30%) were considered high risk and 77 (44%) received g7 dmc for trauma.No significant difference in patient age, gender, or charlson co-morbidity index was present.Patients¿ in the high risk group were found to have a higher bmi and asa.One patient in the high risk group suffered a traumatic dislocation (1.9 %) following a fall in the post operative period.No dislocations were seen in the low risk or trauma groups during this time.None of the patients required revision surgery for dislocation or hip instability.Attempts have been made and no further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: unknown liner, unknown.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.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.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN BEARING
• 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: 17153122
• MDR Text Key: 317503088
• Report Number: 0001825034-2023-01367
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• 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: UNKNOWN BEARING
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.; SEE H10.
• Patient Outcome(s): Other