MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-36-220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Scar Tissue (2060); Synovitis (2094); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2021
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
Clinical notification received for revision of right total hip to address pain/stiffness, with impingement of iliopsoas tendon.Date of implantation: (b)(6) 2020, date of revision: (b)(6) 2021; (right hip).Treatment: revision of cup & 3 screws, liner, and head; s-rom stem retained.
Event or Problem Description
Primary operative notes (b)(6) 2020 indicate the patient received a right total hip replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Mri notes (b)(6) 2021 reveal moderate joint effusion with synovitis and mild tendinosis / scarring of the right gluteus minimus/medius.Revision operative notes (b)(6) 2021 indicate the patient received a right total hip revision due to pain, impingement of iliopsoas tendon and disruption of the posterior capsule repair ¿ it is indicated 2 previous aspirations were performed but did not indicate infection.The patient¿s inflammatory markers are elevated.Upon entering the joint, impingement was identified.The cup was noted to be vertical and replaced.The surgery was completed without indication of complication by the surgeon.
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 health effect - clinical code: appropriate term / code not available (e2402) used to capture the joint disorder (musculoskeletal system (e16)).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 : no device associated with this report was received for examination.Provided patient x-rays have been reviewed.Specific to this device nothing indicative of a product problem is identified.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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 11/13 36MM +3
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11679424
• Report Number: 1818910-2021-08107
• Device Sequence Number: 16889582
• Product Code: LZO
• UDI-Device Identifier: 10603295033578
• UDI-Public: 10603295033578
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

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: 1365-36-220
• Device Catalogue Number: 136536220
• Device Lot Number: 9520077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 05/18/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 04/29/2021; 05/19/2021
• 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: ALTRX +4 NEUT 36IDX52OD; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 52MM; S-ROM*SLEEVE PRX ZTT, 20D-SML; SROM STM STD 36+12L 15X20; ALTRX +4 NEUT 36IDX52OD; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 52MM; S-ROM*SLEEVE PRX ZTT, 20D-SML; SROM STM STD 36+12L 15X20
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 104