MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX40MM; HIP OTHER IMPLANT

Catalog Number 121740500

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

Litigation alleges patient suffers from pain, numbness, weakness, decreased range of motion, and loss of muscle mass and deterioration of soft tissue.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.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

Update 06/15/2016 - pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported metal ion levels to be less than 7 parts per billion, pain, discomfort, decreased range of motion, malposition cup and liner instability.There has been no revision surgery reported malposition of cup and liner instability were addressed on (b)(4).There is no new additional information that would affect the existing investigation.

Manufacturer Narrative

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.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: litigation alleges patient suffers from pain, numbness, weakness, decreased range of motion, and loss of muscle mass and deterioration of soft tissue.Update (b)(6) 2016- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported metal ion levels to be less than 7 parts per billion, pain, discomfort, decreased range of motion, malposition cup and liner instability.There has been no revision surgery reported malposition of cup and liner instability were addressed on com-(b)(4).There is no new additional information that would affect the existing investigation.The complaint was updated on: (b)(6) 2016.Update ad (b)(6) 2018: com-(b)(4) has been re-opened under pc-(b)(4) due to the receipt of ppf and sticker sheets.There were no new allegations and no revision reported.Added law firm.Doi: (b)(6) 2013.Dor: none reported.(left hip).This pc is for the allegations after first revision of the left hip.See pc-(b)(4) for the first revision.

• Brand Name: PINN CAN BONE SCREW 6.5MMX40MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582 0988
• MDR Report Key: 4943537
• MDR Text Key: 6040324
• Report Number: 1818910-2015-26601
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2015

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: Health Professional
• Device Expiration Date: 05/30/2023
• Device Catalogue Number: 121740500
• Device Lot Number: D13030161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/27/2015
• Supplement Dates Manufacturer Received: Not provided; 02/18/2020
• Supplement Dates FDA Received: 07/11/2016; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 136