MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X15MM; BONE SCREWS AND PINS : SCREWS

Model Number	1172-15-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on (b)(6) 2009 for the patient's hip joint.The revision surgery was performed on (b)(6) 2021.The reason of the revision surgery was sudden pain.The surgeon had predicted some problem caused by trunnionosis, however, made an incision and looked at the affected area, there was no metal debris at neck and head, no sign of armd.There was no loosening.The surgeon commented that surprisingly, it was fine.He did not mention the cause of pain.The surgeon removed all implants and inserted new implants (manufactured by another company).The surgery was completed successfully.
Additional 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.
Event or Problem Description
Additional information received indicated that the patient underwent a revision surgery due to pain.The surgeon commented that the pain seemed to be caused by the trunnion, but the taper of the neck and head was unexpectedly clean.
Additional 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.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: CANCELLOUS BONE SCREW 6.5X15MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11398066
• Report Number: 1818910-2021-04078
• Device Sequence Number: 13757981
• Product Code: HWC
• UDI-Device Identifier: 10603295007593
• UDI-Public: 10603295007593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1172-15-000
• Device Catalogue Number: 117215000
• Device Lot Number: C5BFG4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 03/08/2021; 04/16/2021; 05/05/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/04/2021; 03/31/2021; 04/27/2021; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9/10 COCR HEAD 28MM -3.; AML A PLUS 9.0 MM.; CANCELLOUS BONE SCREW 6.5X15MM.; CANCELLOUS BONE SCREW 6.5X15MM.; CANCELLOUS BONE SCREW 6.5X15MM.; CANCELLOUS BONE SCREW 6.5X30MM.; CANCELLOUS BONE SCREW 6.5X35MM.; DURALOC 1200 SERIES 54MM OD.; ENDURON 10D 54OD X 28ID.; 9/10 COCR HEAD 28MM -3; AML A PLUS 9.0 MM; CANCELLOUS BONE SCREW 6.5X15MM; CANCELLOUS BONE SCREW 6.5X30MM; CANCELLOUS BONE SCREW 6.5X35MM; DURALOC 1200 SERIES 54MM OD; ENDURON 10D 54OD X 28ID
• Outcome Attributed to Adverse Event: Required Intervention