MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH STD BRL 3-HOLE PLATE 135 DEG; HIPLOC COMPRESSION PLATE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a trauma procedure (8) years ago.Additionally it has been indicated the patient needs to be revised due to an unknown reason.Plate removal required as confirmed by surgeon.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: hiploc compression screw 36mm, item# 236036, lot# 2015041444 std brl lag scrw 12.5x110mm, item# 236110, lot# 2015092337 report source ¿ foreign ¿ australia multiple mdr reports were filed for this event, please see the associated reports: 3002806535-2023-00094 3002806535-2023-00092 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were not filed for this event.Until more information is available following items: hiploc compression screw 36mm, item# 236036, lot# 2015041444.Std brl lag scrw 12.5x110mm, item# 236110, lot# 2015092337.Remain as associated.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : remains implanted.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.With the available information, a definitive root cause cannot be determined.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.

• Brand Name: STD BRL 3-HOLE PLATE 135 DEG
• Type of Device: HIPLOC COMPRESSION PLATE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16742494
• MDR Text Key: 313337997
• Report Number: 3002806535-2023-00093
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 05019279417933
• UDI-Public: (01)05019279417933(17)250828(10)2015080620
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• 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: 2110-135-003
• Device Lot Number: 2015080620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• 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.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR
• Patient Sex: Male