MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-056

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 40mm liner would not lock in gription cup.Replaced with 36 mm liner.Doe: (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.Additional narrative:  corrected device evaluated by mfr.Added concomitant medical products.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: examination of the returned device confirms the reported observation.There is evidence to indicate the liner was impacted when not properly aligned.The root cause is attributed to inadvertent use error.  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.

• Brand Name: ALTRX NEUT 40IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10104139
• MDR Text Key: 193008752
• Report Number: 1818910-2020-12881
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393344
• UDI-Public: 10603295393344
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1221-40-056
• Device Catalogue Number: 122140056
• Device Lot Number: J6076H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 40IDX56OD.; UNKNOWN HIP ACETABULAR CUP.; ALTRX NEUT 40ID X 56OD; UNKNOWN HIP ACETABULAR CUP
• Patient Age: 70 YR
• Patient Weight: 93