MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887354

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Numbness (2415); No Code Available (3191)

Event Date 12/11/2015

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

Event Description

Litigation alleges patient was revised due to pain, elevated ions and numbness.

Manufacturer Narrative

No device associated with this report was received for examination.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

Ppf alleged elevated metal ions.After review of the medical records, the patient was revised to address fraying and wear.Operative note reported of metallosis with staining of the tissue.

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.Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A photograph of the liner was provided for review.It depicts the backside of the liner.Nothing unusual is noted and nothing indicative of a product problem is identified.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (mre) reviews will not be performed even when product/lot information is known.It has been determined that should related reports be identified an mre is not required.This also applicable to reports of pain.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a device manufacturing (mre) review will not be performed even when product/lot information is known.It has been determined that, for the mom platform and related allegations an mre is not required.This also applicable to reports of pain.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6425379
• MDR Text Key: 70597876
• Report Number: 1818910-2017-15194
• 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: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2017

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: 121887354
• Device Lot Number: 1806882
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: Not provided; 03/08/2019; 10/19/2021
• Supplement Dates FDA Received: 04/25/2017; 03/20/2019; 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR