MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121720500

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The primary surgery was performed on (b)(6) 2015 via tha.It was reported that the revision surgery was performed on (b)(6) 2020 due to loosening of the cup which was caused by the cup side implant¿s projecting floor of the acetabulum.The cup side implant¿s projecting was caused by cup medialization.When the primary surgery, the reaming of acetabular was overdone.During the surgery, the surgeon removed the head, the liner and the cup.The cup was fixed by 2 screws, however, when the surgeon removed 1st screw, the cup was removed easily without removing 2nd screw.Hen, the surgeon set trial implants with zimmer biomet¿s instruments, determined the implant¿s size, set the actual implants temporarily.After that, when the surgeon used chisel to insert flange for ischial bone side, bleeding and blood pressure reductions occurred.The surgeon, an anesthesiologist and orthopedic doctor judged that the surgery had to be stopped.It was thought that the surgeon inserted chisel too deep mistakenly and might damage blood vessel in pelvis.The revision surgery was stopped with over 30 minutes delay, and another revision surgery was planned at a later date.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary =no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Patient code: no code available (3191) is used to capture prolonged surgery and device revision or replacement.Removed not applicable code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected : d2.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected : g3 - the incorrect date was filed on follow up #4 (mwr-12012021-0000875862).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX20MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10586586
• MDR Text Key: 208581158
• Report Number: 1818910-2020-20920
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121720500
• Device Lot Number: D14031813
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 10/19/2020; 11/24/2020; 01/11/2021; 01/11/2021
• Supplement Dates FDA Received: 10/16/2020; 10/20/2020; 11/26/2020; 01/12/2021; 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 32MM -3; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR ETO NEUT 32IDX48OD; PINNACLE SECTOR II CUP 48MM; UNK HIP BONE SCREW; UNKNOWN HIP ACETABULAR CUP; UNK HIP BONE SCREW; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR