MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM -2; HIP FEMORAL HEAD

Catalog Number 136550000

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Discomfort (2330)

Event Type  Injury  

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.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.

Event Description

Litigation received.Litigation alleges discomfort, metal debris, clicking, metallosis, and elevated metal ion levels.

Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the revision surgery notes report a dor: of (b)(6) 2015 and neck/cup impingement.Part/lot numbers provided.The revision surgery noted an indication for surgery included a radiograph reported to show greater trochanteric fragmentation consistent with some degree of either necrosis or osteolysis, but the actual surgery notes do not mention finding either so they will not be added at this time.If/when more information becomes available, an update will be sent.Updated head/liner/stem and added cup.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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

Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

Update (12/5/16) ¿ pfs and medical records received.After review of the medical records for mdr reportability, it was noted in the revision operative note that the surgeon identified necrotic tissue of the anterior superior aspect of the gluteus medius muscle, with a total loss of approximately 60% of that muscle.There is no new additional information that would affect the existing mdr decision.

Event Description

Ppf alleges pseudotumor.

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

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5588074
• MDR Text Key: 43064860
• Report Number: 1818910-2016-17625
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/26/2016

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: 10/01/2011
• Device Catalogue Number: 136550000
• Device Lot Number: 2250327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 09/18/2019; 12/16/2019
• Supplement Dates FDA Received: 06/07/2016; 10/22/2016; 11/30/2016; 12/27/2016; 10/18/2019; 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100