MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM PINN CAN BONE SCREW 6.5MMX15MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121715500

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Fall (1848); Inadequate Osseointegration (2646); No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/24/2011

Event Type  Injury  

Event Description

Ppd and medical records received.This complaint is legal.According to the medical records the patient was revised on (b)(6) 2011 for dislocations and a loose cup.Medical records also indicated they removed a retained cable, but at this time it is unknown why the cable was placed.

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).

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A review of the device history records for the head provided product and lot combination did not reveal any related manufacturing deviations or anomalies.A worldwide complaint database search found no other reported incident(s) against the remaining 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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

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.Udi : (b)(4).E3 initial reporter occupation: lawyer.H6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, it was reported that the patient was revised due to subsequent fall and displacement of the acetabular component.Operative notes reported that the cup was noted to be grossly loose and unstable and was displaced posteriorly.Screws were pulled out from the bone and there was significant bone loss of the posterior wall.Doi: (b)(6) 2011 , dor: (b)(6) 2011 , (right hip).

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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: HIP OTHER IMPLANT: SCREW
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM; 325 paramount drive; raynham MA 02767
• MDR Report Key: 4179267
• MDR Text Key: 5098523
• Report Number: 1818910-2014-30100
• 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,consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2013

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 Catalogue Number: 121715500
• Device Lot Number: 432367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided; 03/01/2021; 04/08/2021
• Supplement Dates FDA Received: 02/05/2015; 03/16/2021; 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 40IDX56OD.; ASPHERE M SPEC 12/14 40 +5.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN SECTOR W/GRIPTION 56MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR