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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.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.H10 additional narrative: added: b5, b7 and h6 (patient).

Event Description

In addition to what were previoulsy reported.After review of the medical records, clinical visit reported rle weaknes, decrease rom, walking difficulty, decrease balance and endurance, wound dehisced and pseudomonas.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.H10 additional narrative: added: b5, h6 (patient).Patient code: no code available (3191) is used to capture osteomyelitis.

Event Description

After review of medical records, visit notes indicated that patient had acute blood loss anemia after 1st revision which required blood transfusion.

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.

• 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
• MDR Report Key: 10296501
• MDR Text Key: 200794806
• Report Number: 1818910-2020-16250
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009795
• UDI-Public: 10603295009795
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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: Health Professional
• Device Model Number: 1217-20-500
• Device Catalogue Number: 121720500
• Device Lot Number: D12042599
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX58OD; ASPHERE M SPEC 12/14 36 -2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN SECTOR W/GRIPTION 58MM; SOL SYS 10/13.5 R BOW
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR