MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122132150

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Adhesion(s) (1695); Synovitis (2094); Unspecified Musculoskeletal problem (4535); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2020

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

Customer is reporting pinnacle pe inlay has been dislocated from the pinnacle cup.Inlay has now been replaced by a new one.Doi: about 2 yrs.Ago, dor: (b)(6) 2020.

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

Event Description

Revision operative notes dated (b)(6) 2020 indicated that the patient received a right total hip revision due to disassociation of the inlay and cup, inlay implant fracture, massive joint adhesions and synovitis.The head and liner were revised, fragments of fractured liner were removed, synovectomy, excision of adhesions and thorough irrigation of the joint were completed.The surgery was completed without indication of complication by the surgeon.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of returned acetabular liner and provided x-ray images does find evidence to support a disassociation event.The device manufacturing records have been reviewed.No related deviations or anomalies identified.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 device manufacturing records have been reviewed.No related deviations or anomalies identified.Device history review : the device manufacturing records have been reviewed.No related deviations or anomalies identified.Corrected: h3.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: examination of returned acetabular liner and provided x-ray images does find evidence to support a disassociation event.The device manufacturing records have been reviewed.No related deviations or anomalies identified.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 device manufacturing records have been reviewed.No related deviations or anomalies identified.Device history review: the device manufacturing records have been reviewed.No related deviations or anomalies identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of returned acetabular liner and provided x-ray images does find evidence to support a disassociation event.The device manufacturing records have been reviewed.No related deviations or anomalies identified.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 device manufacturing records have been reviewed.No related deviations or anomalies identified.Device history review: the device manufacturing records have been reviewed.No related deviations or anomalies identified.Corrected: h3, h6 (clinical code).H6 clinical code: the reported appropriate term / code not available (e2402) to capture injury (e20) is now being replaced with unspecified musculoskeletal problem (e1635).

• Brand Name: ALTRX +4 10D 32IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11123556
• MDR Text Key: 225282271
• Report Number: 1818910-2021-00426
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 122132150
• Device Lot Number: HU8728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/11/2021; 02/19/2021; 03/16/2021; 11/29/2021; 12/01/2021
• Supplement Dates FDA Received: 01/28/2021; 02/24/2021; 03/16/2021; 11/30/2021; 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 14; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE CUP; PINNACLE SECTOR II CUP 50MM; PINNACLE CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 58 KG