MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 BM HO 15.0; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source foreign: australia.Medical products: unknown-unknown femoral head-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01676.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision surgery 1-day post implantation due to dislocating.Surgeon believed that the reason of the dislocation was inappropriate horizontal offset and he was able to rectify this by changing the stem from ho to a std offset taperloc.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined; it was mentioned that the surgeon may have misjudged which stem to use however without medical records this cannot be confirmed.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant product 650-1163-delta cer fem hd 32/-3mm t1-3066357 010000927-g7 hi-wall e1 liner 32mm e-7046529 110010244-g7 osseoti 3 hole shell 52mm e-7213837 51-116120-tprlc 133 mp type1 bm so 12.0-6763121 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision surgery approximately 1-day post implantation due to instability.The surgeon believes he misjudged the horizontal offset required for the patient and revised the ho stem to std stem and in turn reducing the horizontal offset and this made the patient stable.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC 133 MP TYPE1 BM HO 15.0
• 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: 15084197
• MDR Text Key: 296386355
• Report Number: 0001825034-2022-01674
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00880304513181
• UDI-Public: (01)00880304513181(17)270312(10)6002168
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-117150
• Device Lot Number: 6002168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/02/2022; 08/15/2022
• Supplement Dates FDA Received: 08/11/2022; 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2017
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 83 KG