MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX20MM; HIP OTHER IMPLANT

Catalog Number 121720500

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)

Event Date 04/25/2014

Event Type  Injury  

Event Description

The patient was revised because of a loose cup with some osteolysis.

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.

Manufacturer Narrative

The devices associated with this report were not returned.A review of the device history records for the c68ek4000 lot code did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.Medical records were obtained and reviewed by a medical professional.With the limited amount of information provided, it cannot be determined that the complaint is product related.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for 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

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.

Event Description

Update rec'd 7/25/2014- pfs and medical records received.After review of the medical records there is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

The patient was revised because of a loose cup with some osteolysis.(b)(4).The devices associated with this report were not returned.A review of the device history records for the c68ek4000 lot code did not reveal any related manufactuirng deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for 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

Additional info: update rec'd 7/23/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, discomfort, and decreased mobility.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Added: (patient).

Event Description

Update ad 13 apr 2018: ppf, pfs and medical records received.In addition to what were previously alleged, pfs also alleges walking difficulty and difficulty carrying out normal daily activities.Ppf has no new allegation.After review of medical records for mdr reportability, it was stated that the patient was revised to address loosening of the cup and elevated metal ion levels.Revision notes reported a small cyst, 15 cc of brown cloudy fluid consistent with metallosis, osteolytic lesion, two screws were removed easily, and metal debris throughout the adjacent soft tissue.Added stem due to the reported elevated metal ion levels but was not revised.There were no reported lab results.Doi: (b)(6) 2009; dor: (b)(6) 2014; left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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 will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX20MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 3816587
• MDR Text Key: 4404223
• Report Number: 1818910-2014-18973
• 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: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 121720500
• Device Lot Number: C68EK4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 147