MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 CORAIL AMT SZ15 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for heterotopic ossificans & tingling in thigh associated with the bone growth.Event is serious and is considered severe.There is a remote possibility that the event is related to device and is definitely related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (right hip).On (b)(6) 2021, the patient underwent a right hip surgical intervention to address heterotopic ossification.The patient was experiencing decreased range of motion prior to the operation.The surgeon noted a small amount of remaining necrotic bone that was far posterior to the tip of the trochanter and not going to affect any range of motion, this was left.No products were revised.There were no indicated intra-operative complications.On (b)(6) 2021, the patient presented for a right hip evaluation following heterotopic ossification removal.The patient was continuing to experience paresthesia and increased burning in the area.An x-ray revealed a small piece of bone off the greater trochanter, however, the surgeon thought it was unrelated to heterotopic ossification, likely a small avulsion.The patient was prescribed po gabapentin.There is no evidence of revision or invasive treatment.
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.

• Brand Name: CORAIL AMT SZ15 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12821124
• Report Number: 1818910-2021-25216
• Device Sequence Number: 5475693
• Product Code: LPH
• UDI-Device Identifier: 10603295455349
• UDI-Public: 10603295455349
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: L971115
• Device Catalogue Number: L971115
• Device Lot Number: 9196323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX54OD; CORAIL AMT SZ15 135 HIGH COL; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White