MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM; PINNACLE MTL INS NEUT36IDX54OD

Catalog Number 121887354

Device Problems Corroded (1131); Material Disintegration (1177); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/10/2016

Event Type  malfunction  

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 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

Oct 24, 2017: litigation received.Litigation alleges pain and elevated metal ion levels in the blood.Revision reported metallosis and pseudotumor, described as blackened pseudotumor present along the posterior capsule that extend up into the region of the abductors and trochanteric bursa and corrosion on the taper of the femoral component.This complaint was updated on oct 31, 2017.

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

Event Description

In addition to what was previously litigated, patient also alleges right groin discomfort, developed numbness in her legs, spasms, decreased range of motion.Patient continues to experience muscle tightness, pain and intermittent muscle spasm.After review of medical records for mdr reportability it was reported that the patient was revised to address metallosis and pseudotumor.The patient has developed elevated cobalt and chromium levels.An mri examination shows pseudotumors around both hips.Revision note reported cloudy fluid in the joint.There was some blackened pseudotumor present along the posterior capsule that extended up into the region of the abductors and trochanteric bursa.There was some corrosion on the taper of the femoral component.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what previously alleged, ppf alleges metal wear.Doi: (b)(6), 2008 - dor: (b)(6), 2016 (left hip).

Manufacturer Narrative

(b)(4).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.

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.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.

• Brand Name: UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM
• Type of Device: PINNACLE MTL INS NEUT36IDX54OD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7046104
• MDR Text Key: 92535072
• Report Number: 1818910-2017-29438
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887354
• Device Lot Number: 2436899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 114