MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNIVERSAL 2.7MM LOCKING SCREW 14MM LENGTH; PLATE, FIXATION

Model Number N/A

Device Problem Degraded (1153)

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The 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.(b)(4).Concomitant devices ¿ zimmer periarticular locking distal lateral fibular plate catalog #: 00235701704 lot #: 63460598, periarticular self-tapping cortical bone screw 3.5mm diameter 24mm length catalog #: 00234802435 lot #: 63016356, periarticular self-tapping cortical bone screw 3.5mm diameter 12mm length catalog #: 00234801235 lot #: 63489132, periarticular self-tapping cortical bone screw 3.5mm diameter 12mm length catalog #: 00234801235 lot #: 63489132, periarticular self-tapping cortical bone screw 3.5mm diameter 12mm length catalog #: 00234801235 lot #: 63537713, zimmer universal 2.7mm locking screw 14mm length catalog #: 00482801402 lot #: 63149521, zimmer universal 2.7mm locking screw 16mm length catalog #: 00482801602 lot #: 63373028, zimmer universal 2.7mm locking screw 16mm length catalog #: 00482801602 lot #: 63423846.This report is number 6 of 9 mdrs filed for the same patient (reference 0001822565-2017-03992 / 03997 / 03998 / 03999 and 0002648920-2017-00388 / 00389 / 00390 / 00391).Returned, not yet evaluated.

Event Description

It is reported that a patient underwent a right ankle plate removal procedure due to pain, redness and swelling approximately four (4) months post-operatively.The revision operative notes indicate that the patient was being revised to remove right ankle fixation implants due to pain.It was noted, "there was some brownish material on the plate.Screws were taken out of the plate.The brown tissue was also underneath the plate on the distal fibula.The wound was then thoroughly irrigated and closed.".

Manufacturer Narrative

Reported event was confirmed by review of the provided op notes.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.The medical notes supplied indicated that when the radiographs were reviewed the fracture had healed nicely.It was also noted that there was evidence of localized soft tissue irritation.The patients pain continued to be worse.An elemental analysis of the returned plate and screw samples was completed.The suspected corrosion indications on the plate and screw samples were analyzed by eds and they showed the following foreign elements in the decreasing order of their weight percentages.Plate: o, p, ca, and cl; screw: o, na, cl, p, mg, al, and ca;.The rest of the composition of the eds spectra was consistent with base materials of plate and screw.A definite root cause cannot be concluded.A summary of the investigation is being sent to the complainant 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.

• Brand Name: ZIMMER UNIVERSAL 2.7MM LOCKING SCREW 14MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6636705
• MDR Text Key: 77431968
• Report Number: 0001822565-2017-03995
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00482801402
• Device Lot Number: 63470823
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR