MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; HIP ACETABULAR LINERS

Catalog Number 121887458

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Physical Asymmetry (4573)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the ultamet 58x40 metal liner, and 40x1.5 head was removed and replaced with poly liner and new head.Metalosis.Doi: (b)(6) 2010; dor: (b)(6) 2020; 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.H10 additional narrative: corrected: h6 product complaint # (b)(4).Investigation summary
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> 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.

Event Description

After review of medical records the patient was revised due to metallosis.Revision notes stated that head and liner were removed.Metal debris was noted behind metal liner and the trunnion inside the head.The liner was noted to have black staining metal debris.Patient was 2 inches short on opposite side, experienced decrease range of motion, pain and elevated metal ion.Doi: (b)(6) 2010, dor: (b)(6) 2020 , (left hip).

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.E3 initial reporter occupation: lawyer.Patient code: no code available (3191) is used to capture limb asymmetry and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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: a device history record (mre) review, was not possible because the required lot code was not provided.

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

Event Description

In addition to what previously alleged, records allege injury, metallosis, limited daily activities, emotional trauma and distress.

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

Event Description

Medical records received.On 02/06/2020, the operative noted black staining metal debris was found in the liner.

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.Investigation will be updated as applicable.Device history lot : a device history record (mre) review, was not possible because the required lot code was not valid.

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

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.

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

Event Description

Medical records received.In addition to what was previously reported in the medical records.After review of the records the patient was revised to address metallosis, limited ranged of motion, tenderness and weakness operative note reported backside wear of metal liner.Metal debris noted diffusely scattered in the anterior portion of the joint and was concentrated behind the metal liner.The trunnion inside the head is far as metal debris but no abnormal wear notching or scratching of the trunnion.The head had appropriate fixation, impacted on it made sure it fit and had no wobble or wear.Noted liner had black staining metal debris.Knee and ankle heights were uneven.

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

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9741621
• MDR Text Key: 188681149
• Report Number: 1818910-2020-05715
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2014
• Device Catalogue Number: 121887458
• Device Lot Number: 2961093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+1.5; 12/14 ARTICUL 40MM M SPEC+1.5; APEX HOLE ELIM POSITIVE STOP; TRI-LOCK BPS SZ 5 STD OFFSET; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White