MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXTRACTOR ADAPTER; HIP INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 574201085 ¿ avenir stem ¿ 3102389.The product is in process of being returned to zimmer biomet for the investigation.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during a right hip revision, the surgeon was attempting to remove the stem when the connecting bolt for the slap hammer sheared off.The stem was not able to be removed and the broken piece of the instrument remained in the wound.The surgeon decided to leave the stem implanted.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: g3; h2; h3; h6 visual examination of the returned product identified it is confirmed that the thread is fractured and partly missing.The part also shows wear and damage.Additionally, the device was submitted for further analysis.Analysis determined the fracture revealed river lines artifacts all flowing in one direction towards a suspected hinge at its edge, suggesting a bending overload mode of fracture.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: multiple attempts made to explant the stem with a backslap hammer and osteotomes, stem well fixed and unable to be removed, surgeon elected to leave the stem rather than eto.At this point, the back slapping attachments broke off in the stem with only the threads being full of the metal of the extraction device and no prominent portion of the back slapper to be grasped in order to be removed.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 event information to report at this time.

• Brand Name: EXTRACTOR ADAPTER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16408426
• MDR Text Key: 309878152
• Report Number: 0001822565-2023-00421
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024509825
• UDI-Public: (01)00889024509825(10)64666143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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: 574777110
• Device Lot Number: 64666143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male