MAUDE Adverse Event Report: ZIMMER, INC. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

(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.Initial dos: 1995.Revision dos: (b)(6) 2014.Bone screw - 00625006530 ¿ one of two possible screws were reported to have fractured.Lot number is 62527261.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04659 and 0001822565-2017-04660.

Event Description

It was reported that the patient was revised approximately nineteen years post-implantation due to loosening, fracture and lack of bony ingrowth around the cup.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient was revised approximately nineteen years post-implantation due to loosening, fracture, and lack of bony ingrowth around the cup.Subsequently, the patient has been experiencing pain, unable to use steps, limited mobility, unable to do physical therapy stretches, and unable to ride a bike.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: shell with cluster holes porous 68 mm o.D.Size qu for use with qu liners cat: 00875706801 lot: 62387040.Bone scr 6.5x30 self-tap cat: 00625006530 lot: 62527261.Unknown stryker femoral head.Unknown stryker pca stem.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Zimmer-biomet has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product as indicated on the packaging insert.However, it cannot be confirmed that this incompatibility has any definitive relationship to the reported event.The x-rays provided were reviewed by an external surgeon, who noted: left total hip arthroplasty without hardware failure or loosening is present.No radiolucency.Heterotopic ossification along the superior and lateral acetabulum.Acetabular protrusio of the left hip is present.Images were, however, noted to be suboptimal and poor quality.Root cause was unable to be determined.A summary of the investigation has been 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.

Manufacturer Narrative

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.

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 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 6.5X40 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• 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: 6694918
• MDR Text Key: 79352440
• Report Number: 0001822565-2017-04660
• 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,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00625006540
• Device Lot Number: 62436823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• 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: 79 YR
• Patient Weight: 68