MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-1163- delta cer fem hd 32/-3mm t1- 3103857, 51-103160- tprlc 133 t1 pps so 16x152mm- 6161620, 00632006032- modular cup 20 degree liner longevity 60x32- 64240050, 00620206022- tm modular cup 60mm cluster-hole- 64553159, 51-103160- tprlc 133 t1 pps so 16x152mm- 6537240, 650-1161- delta cer fem hd 32/+3mm t1-3090603.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported stem and head were implanted.After reducing, surgeon wanted to change head sizes.A tamp was introduced and attempted to remove implanted head.Subsequently, the head would not free from stem.Had to remove stem and head as a monoblock construct.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 h6 component code: mechanical (g04) - stem visual examination of the returned product identified the stem is seized to the returned ceramic head.Visual inspection found the stem to be in good overall condition.Impact marks are present on the shoulder and neck.A small amount of debris was observed in the porous coating on the stem's spine.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 Description

No additional information on the reported event.

• Brand Name: TPRLC 133 T1 PPS SO 16X152MM T1
• Type of Device: PROSTHESIS, 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: 15075410
• MDR Text Key: 304687040
• Report Number: 0001825034-2022-01666
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304489691
• UDI-Public: (01)00880304489691(11)171112(10)6161620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-103160
• Device Lot Number: 6161620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1