MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X30; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Cancer (3262)

Event Date 08/18/2018

Event Type  Injury  

Event Description

It was reported that the patient underwent a total hip arthroplasty on an unknown date.Subsequently, the patient experienced pain due to loosening of the cup and screw fracture.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00875706001, lot number: 64049358; brand name: acetabular shell.Catalog number: 00885101440, lot number: 63831459; brand name: acetabular liner.Catalog number: 00786401400, lot number: 63985581; brand name: femoral stem.Catalog number:00877504001, lot number: 2935332; brand name: femoral head.Catalog number:00625006530 , lot number: 64047518; brand name: bone screw.Multiple reports were submitted along with this report 0001822565-2022-01682.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.A month later, the patient was still experiencing pain and stiffness, but is not an unexpected finding.The patient was suffering from severe pain and inability to bear weight.A revision occurred for loosening of the stem implant, however a broken screw was not identified within the op notes or diagnosis.X-rays taken the same day as the revision showed a possible broken screw component, but it could not be confirmed.The stem and head were explanted and zimmer products were placed.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not 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

It was reported that the patient was revised due to pain and loosening approximately two (2) years post implantation.On an x-ray completed prior to the revision, it appeared that there was a broken screw component projected over the lateral cortex but is unable to be confirmed based upon operative note, operative diagnosis, explanted product, or additional imaging.During the revision, the stem and the head were revised and all other components remained in place.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported a right total hip revision was performed approximately 2 years post implantation due to pain and loosening.Additionally, a periprosthetic distal end femoral stress fracture was noted on x-ray (but not confirmed in revision notes).On an x-ray, completed after the revision, it appeared that there was a broken screw component projected over the lateral cortex but is unable to be confirmed based upon operative note, operative diagnosis, explanted product, or additional imaging.During the revision, the stem and the head were revised with zb products and all other components remained in place.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a5; b4, b5, b7, g3, h2, h6.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified: the patient was complaining of pain at an office visit, and an x-ray showed a subtle stress fracture around the shaft of the stem with callus formation.An mri 2 days later showed a muscle strain.The bone fracture was not confirmed in the revision notes.Root cause unchanged.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: BONE SCR 6.5X30
• 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): .; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14641976
• MDR Text Key: 293609070
• Report Number: 0002648920-2022-00138
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)310528(10)64047518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: 00625006530
• Device Lot Number: 64047518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2018
• 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): Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White