MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Hypovolemia (2243)

Event Date 07/08/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620206622 shell porous with cluster holes 66 mm, 00630506636 liner standard 3.5 mm offset 36 mm i.D.For use with 66 mm o.D.Shell, 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05186, 0001822565 - 2019 - 05187, 0001822565 - 2019 - 05188.

Event Description

It was reported the patient underwent removal of an antibiotic cement spacer with placement of a revision total hip system after a complicated periprosthetic infection.The patient experienced another hip infection leading to irrigation and debridement of the joint without product exchange per patient request.Subsequently, the patient was revised approximately six months post implantation due to ongoing infection.Patient underwent removal of all tha components with placement of an antibiotic spacer.Operative report stated pseudocapsule debrided with a lot of blood drained from the membrane and significant heterotopic ossification present and removed.Wound healing as expected, intraop cultures were negative.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be was reported under the incorrect mfr #.The initial report was forwarded in error and should be voided.This event will be reported under mfr # 0002648920-2020-00207.

Event Description

Upon reassessment of the reported event, it was determined to be was reported under the incorrect mfr #.The initial report was forwarded in error and should be voided.This event will be reported under mfr # 0002648920-2020-00207.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9437095
• MDR Text Key: 170028768
• Report Number: 0001822565-2019-05189
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 62157211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 03/05/2020; 03/11/2020
• Supplement Dates FDA Received: 03/09/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 125