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

Catalog Number 121720500

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

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Nausea (1970); Pain (1994); Anxiety (2328); Depression (2361); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Complaint description: patient was revised to address infection.Update: 10/26/2015 - litigation received.Litigation alleges patient suffers from pain.The head and liner are now being reported.In addition to what were previously alleged, ppf alleges metal wear, metallosis and bone fracture.Added lawyer and law firm.Updated patient initials.

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Pfs alleges lack of mobility, chronic insomnia, mental and emotional strain, felt ill(anxiety, depressed, nausea, tired).After review of medical records, patient was revised to addressed septic right hip arthroplasty.Operative notes indicated cloudy fluid upon in fascia.There was a huge thick capsule over greater trochanter.The medial portion of the bone inadvertently did crack.Confirmed in medical records that fracture was on femur.Doi: (b)(6) 2010; dor: (b)(6) 2015; right hip.

Manufacturer Narrative

This medwatch report is being retracted since it was found that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the device.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 9383063
• MDR Text Key: 168210604
• Report Number: 1818910-2019-118358
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009795
• UDI-Public: 10603295009795
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Catalogue Number: 121720500
• Device Lot Number: 417222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 12/03/2019; 12/23/2019
• Supplement Dates FDA Received: 12/18/2019; 12/20/2019; 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 118