MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM BONE SCREWS AND PINS : SCREWS

Model Number 1217-20-500

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

Patient Problems Wound Dehiscence (1154); Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); No Code Available (3191)

Event Date 01/15/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address infection. Loosening of the cup and stem due to the infection was also reported. Update ad 2 jul 2020: (b)(4) has been re-opened under (b)(4) due to medical records received. After review of medical record, the patient was revised to address infection, osteomyelitis, pain, fracture of the greater trochanter and heterotopic bone formation along the medical calcar. Persistent purulent drainage from her lateral hip wound. Operative note reported abundant amount of fibrous tissue surrounding the hip joint. Frozen section revealed acute inflammation consistent with infection. Stem revealed it to be grossly loose. Notable drainage from her right hip wound. Removal of tha with placement of antibiotic impregnated spacer, biopsy, i and d were performed. Doi: (b)(6) 2012: dor: (b)(6) 2013: right hip 2nd revision (head and stem). Doi: (b)(6) 2012: dor: (b)(6) 2013: right hip (cup, linear and screws). Added revision hospital, medical history, dob, height, ethnicity, race, law firm name, patient harm, litigation box was ticked, pe code for the stem and concomitant products. Added product details for screws. Corrected patient identifier. This complaint was reviewed and updated on jul 13, 2020.

• Brand Name: PINN CAN BONE SCREW 6.5MMX20MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10296501
• MDR Text Key: 200794806
• Report Number: 1818910-2020-16250
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1217-20-500
• Device Catalogue Number: 121720500
• Device Lot Number: D12042599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/20/2020 Patient Sequence Number: 1