MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX50MM; HIP OTHER IMPLANT

Catalog Number 121750500

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Information (3190); No Code Available (3191)

Event Date 04/13/2015

Event Type  Injury  

Event Description

Pfs and medical records received.Medical records indicate the patient was revised for chronic infection on (b)(6) 2015.During this revision all implants were removed and spacers were placed.While trying to remove the two acetabular screws the head became stripped.The patient was previously revised on (b)(6) 2015 ((b)(4)) and there was no clinical evidence of infection.The liner and femoral head placed on (b)(6) 2015 are being reported for the infection and the two screws are being reported for being stripped.The stem has already been reported on (b)(4), but the cup isn't being reported as infection wasn't alleged on the pfs.

Manufacturer Narrative

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

Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

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.

Event Description

Update 11/25/2015- pfs and medical records received.Pfs and medical records were reviewed for mdr reportability.Amended pfs reported grinding, throbbing, limited range of motion and difficulty standing and walking.Pfs still doesn't allege any infection.The revision surgery report also noted significant hardware from the previous motor vehicle accident repair.The medical records reported two positive cultures from aspiration without dates of results.The components were removed and an antibiotic space placed in stage i of a two stage revision.There was no report of grinding within the medical records.The head and liner reported on this complaint are being rejected as they are also reported on (b)(4).There is no new additional information that would affect the existing investigation.The complaint was updated on: dec 16, 2015.

Manufacturer Narrative

Added: patient code.

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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX50MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4798799
• MDR Text Key: 5915872
• Report Number: 1818910-2015-21843
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2014
• Device Catalogue Number: 121750500
• Device Lot Number: YN4JP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 74