MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-30-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Weakness (2145); Hypoesthesia (2352); No Code Available (3191)

Event Date 04/22/2020

Event Type  Injury  

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 Description

Clinical adverse event received for femoral nerve palsy postoperative: foot drop event is not serious and is considered mild there is a remote possibility that the event is related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right hip).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The provided x-ray images could not confirm the reported allegations.The root cause could not be confirmed.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.

Event Description

Additional information received for medical records.Patient received a right depuy tha to treat end-stage arthrosis.The hip was placed with an anterior surgical approach.Two dome screws were used to secure the cup.After implantation, fluoroscopy showed a well-placed stem in neutral alignment and the cup in excellent position.The procedure was completed without complications.Clinic note dated (b)(6) 2022.Patient presented 6 weeks s/p tha with a partial femoral nerve palsy with foot drop.The surgeon notes that the patient has difficulty initiating his hip flexors, has noted quadriceps weakness, and femoral numbness.The surgeon notes that the patient has a history of lumbar stenosis and neuropathy, but believes this palsy is related to the anterior approach used to implant the tha.The patient reports one minor fall, with no pain or discomfort.No treatment is prescribed.Clinic note dated (b)(6) 2020.Patient presents 3 months s/p right tha.Physical exam shows some return of felling and function.The patent is still unable to do a straight leg raise.The physician refers the patient for a nerve conduction study and an mri.No treatment is prescribed, and the patient will follow-up in 3 months.

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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10247998
• MDR Text Key: 198099412
• Report Number: 1818910-2020-15349
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010159
• UDI-Public: 10603295010159
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-30-500
• Device Catalogue Number: 121730500
• Device Lot Number: D19113808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX54OD; CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 98