MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT; PROSTHESIS, HIP

Catalog Number	00489406630
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3005751028 - 2020 - 00058.Concomitant medical product(s): unk liner; unk stem; stryker restoration cup 56 mm part#1235-2-562 lot#g5830067; stryker x3 size 28/56 insert part#1236-2-856 lot#306413; cer option type 1 tpr sleve +6 pe 1 part#650-1068 lot#646880; delta ceramic option head dia2 8 part#650-1055 lot#195030.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.3rd revision op notes dated (b)(6) 2016 demonstrated that the patient was revised due to cup loosening.Same bone loss was identified around femur and acetabulum as what was identified in the previous surgery.Acetabular augment had lost it fixation to the bone and spontaneously de-coupled from the acetabular component.Acetabular component was moving slightly but was not grossly loose.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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
Legal counsel for patient reported that patient underwent an additional left hip revision arthroplasty approximately 5 months after the previous surgery due to loosening of the acetabular components.No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10008067
• Report Number: 3005751028-2020-00059
• Device Sequence Number: 2785219
• Product Code: LPH
• UDI-Device Identifier: 00889024306950
• UDI-Public: (01)00889024306950
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K042871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: 08/31/2020
• Device Catalogue Number: 00489406630
• Device Lot Number: 63020448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2018
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention