MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X30MM; BONE SCREWS AND PINS : SCREWS

Model Number	1172-30-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Received a x-ray of a post thr patient, seems a broken stem from the neck and looks jnj corail pinnacle product.Patient was complaining severe pain in right side of hip, inability to stand and inability to walk.Patient also informed surgeon that he got fallen during his routine work.Patient also informed to surgeon that his right hip was already operated in 2018 due to avn by any other surgeon from the patna, & rt hip was implanted with jnj product.And patient has also reported that he is having pain in his rt hip (operated site) and getting some unusual sound since last one year.
Additional Manufacturer Narrative
Product complaint # : (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
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.H6 patient code: no code available (3191) is used to capture surgery prolonged.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 product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: CANCELLOUS BONE SCREW 6.5X30MM
• 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: 10022558
• Report Number: 1818910-2020-11669
• Device Sequence Number: 19511890
• Product Code: HWC
• UDI-Device Identifier: 10603295007623
• UDI-Public: 10603295007623
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1172-30-000
• Device Catalogue Number: 117230000
• Device Lot Number: HA9366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 05/27/2020; 06/23/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/08/2020; 06/12/2020; 07/13/2020
• 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: CANCELLOUS BONE SCREW 6.5X20MM; CANCELLOUS BONE SCREW 6.5X30MM; CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 36MM +8.5; EA DELTA CER INSERT 36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR