MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121730500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 05/16/2014

Event Type  Injury  

Event Description

Pfs and medical records received.Pfs alleges infection and fracture.This complaint is legal.After review of the medical records for mdr reportability, the patient was taken back to the operating room on (b)(6) 2014 for a washout due to infection and the head/liner was exchanged.The patient was taken back to the o.R.On (b)(6) 2014 for infection again and all implants were removed and spacers were placed.During removal the stem a fracture in the femur occurred (this isn't being added as a patient harm as it occurred while the stem while being removed).Metallosis was noted around the screws and cup.The cup has already been reported on (b)(4).The liner and head placed (b)(6) 2014 are not being reported as the patient was already infected.The patient was reimplanted on (b)(6) 2014.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Manufacturer Narrative

Pfs and medical records received.Pfs alleges infection and fracture.This complaint is legal.After review of the medical records for mdr reportability, the patient was taken back to the operating room on (b)(6) 2014 for a washout due to infection and the head/liner was exchanged.The patient was taken back to the or on (b)(6) 2014 for infection again and all implants were removed and spacers were placed.During removal the stem a fracture in the femur occurred (this isn't being added as a patient harm as it occurred while the stem while being removed).Metallosis was noted around the screws and cup.The cup has already been reported on com (b)(4).The liner and head placed (b)(6) 2014 are not being reported as the patient was already infected.The patient was reimplanted on (b)(6) /2014.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A review of the manufacturing records and sterilization certification identified that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

After review of medical records, the patient was revised due to infected right total hip bony ingrown arthroplasty.Operative notes indicated a cyst of staph and abscess from distal from the joint, from the acetabular cup and form the femoral canal.It was also indicated that a fracture as encountered during trochanteric osteotomy.

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.  .

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: h6 (patient,device).No code available is used to capture surgical intervention.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: HIP OTHER IMPLANT: SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4439643
• MDR Text Key: 5318343
• Report Number: 1818910-2015-11700
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2015

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
• Device Operator: Physician
• Device Catalogue Number: 121730500
• Device Lot Number: C4YKM4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 01/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/10/2019; 07/10/2020
• Supplement Dates FDA Received: 03/31/2015; 03/31/2015; 09/20/2019; 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104