MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS STEM CLRD HO 7; HIP IMPLANT FEMORAL STEM

Model Number	4742-07-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Physical Asymmetry (4573)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for post operative sciatic nerve pain.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021.Date of event: (b)(6) 2021.(right hip).Treatment: exploration was performed and there was no evidence of tethering.The nerve was palpated and found to be free of any tension.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary = > no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Based on the photographic evidence nothing indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records evaluation (mre) was not performed.Corrected: d6a.
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.
Event or Problem Description
Doi: (b)(6) 2022: patient received a right tha to treat end-stage osteoarthritis.The patient received an emphasys stem, pinnacle cup, cocr head, and altrex liner.The surgeon notes that, due to the patient¿s anatomy, the stem sat a little proud resulting a minimal lengthening of the right leg causing a slight leg length discrepancy.The procedure was completed without complications.Doe: (b)(6) 2022: after the spinal anesthesia wore off, the patient complained of sciatic pain.The patient was brought back to the or to determine if the sciatic nerve was tethered with one of the sutures.Upon entering the joint, the surgeon determined that the sciatic nerve was not tethered nor tight.No operative corrections were performed.The procedure was completed without complications.Clinic note dated (b)(6) 2022: patients foot drop and sciatic nerve palsy are completely resolved.The patient does have limb asymmetry, with the right leg slightly longer than the left.The patient is prescribed a 9 mm shoe lift.

• Brand Name: EMSYS STEM CLRD HO 7
• Common Device Name: HIP IMPLANT FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15788123
• Report Number: 1818910-2022-22798
• Device Sequence Number: 12150798
• Product Code: MEH
• UDI-Device Identifier: 10603295505570
• UDI-Public: 10603295505570
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K211657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 4742-07-200
• Device Catalogue Number: 474207200
• Device Lot Number: 3763255
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 12/16/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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 +4 NEUT 36IDX52OD; ARTICULEZE M HEAD 36MM +8.5; EMSYS STEM CLRD HO 7; PINNACLE SECTOR II CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White