MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ ACETABULAR REVISION SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00489407015, tm acetabular augment, lot # 62524031.00489406630, tm acetabular augment, lot # 62538657.00625006535, bone screw, lot # 63391617.00625006540, bone screw, lot # 63622283.00625006560, bone screw, lot # 60945763.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3005751028 - 2020 - 00003, 3005751028 - 2020 - 00004.
Event or Problem Description
It was reported that approximately 2.5 years post implantation, the patient was revised due to loosening.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No products or images were received for review.Provided x-rays were reviewed by a healthcare professional and identified the following: dislocation of the left hip arthroplasty implants as noted with implant loosening and displacement.There is a complex acetabular implant system with loosening and displacement of an acetabular implant from the existing acetabular cup.Lucency reflecting osteolysis is present along the acetabular cup.Screw fragments are present at the superolateral acetabulum and an existing screw at the inferomedial acetabulum is surrounded by radiolucency and appears loose.Review of the device history records did not identify any deviations or anomalies during manufacturing.A definitive root cause was unable to be determined.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 available at the time of this report.

• Brand Name: TRABECULAR METAL¿¢ ACETABULAR REVISION SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9546734
• Report Number: 3005751028-2020-00002
• Device Sequence Number: 2245178
• Product Code: JDI
• UDI-Device Identifier: 00889024310940
• UDI-Public: (01)00889024310940
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00700007020
• Device Lot Number: 63436336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention