MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/15/2016

Event Type  Death  

Manufacturer Narrative

The complaint number corresponding to this medwatch is (b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.(b)(4) avenirâ® mã¼ller, stem, (b)(4); (b)(4) trabecular metalâ¿¢ acetabular revision system, buttress augment (b)(4); (b)(4) trabecular metal â¿¢ acetabular revision system, column buttress, (b)(4); (b)(4) trabecular metalâ¿¢ acetabular revision system, column buttress, (b)(4); (b)(4) shell with multi holes porous (b)(4); (b)(4) femoral head product (b)(4); (b)(4) constrained liner with ring (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-05117, 0002648920-2017-00470, 0001822565-2017-05118, 00002648920-2017-00471, 0002648920-2017-00472, 0002648920-2017-00473, 0002648920-2017-00474, 0002648920-2017-00475, 0002648920-2017-00476, 0002648920-2017-00477 & 0002648920-2017-00478.

Event Description

It was reported by patient's legal counsel that the patient died approximately two years post implantation due to respiratory failure related to chondrosarcoma.The proximate cause of her death was infection and necrosis from negligence during and after surgery.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Dhr indicates the device was sterilized to specifications.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported by patient's legal counsel that the patient died approximately two years post implantation due to respiratory failure related to chondrosarcoma.The proximate cause of her death was infection and necrosis, treated with amputation, from negligence during and after surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was identified an internal software error produced and submitted an invalid d2 device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 further information available.

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6736575
• MDR Text Key: 80816958
• Report Number: 0002648920-2017-00472
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: 62640321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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): Death
• Patient Age: 43 YR