MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Hematoma (1884); Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date, the surgery was performed via tha with an unknown implant.On an unknown date, suspected pseudotumor was confirmed.Because a large tumor is in the abdominal cavity, the tumor will be removed, and a revision will be performed in two stages.The surgery date has not yet been scheduled.No further information is available.New information has been received as follows: on (b)(6) 2023, the tumor was removed due to the diagnosis of chronic expanding hematoma.The implant revision is scheduled to be performed on december 4.Neither the cup nor the stem is unstable currently, but the liner is showing some wear, so replacement of the head and liner is planned.In the revision surgery, if cup instability is observed intraoperatively or if corrosion is observed at the head/neck junction, a full revision will be scheduled.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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

Additional information was received and stated that the implant revision surgery scheduled for december 4th was canceled because the patient was found to have pancytopenia of unknown cause.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that on an unknown date, the surgery was performed via tha with an unknown implant.On an unknown date, suspected pseudotumor was confirmed.Because a large tumor is in the abdominal cavity, the tumor will be removed, and a revision will be performed in two stages.The surgery date has not yet been scheduled.No further information is available.The product was not returned to depuy synthese, however photos were provided for review.See attachment [photo_(b)(4) _(b)(6) hospital (jo202300534].The x-ray investigation was not able to identify the reported wear.Nothing indicative of a device nonconformance was found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the [unknown hip acetabular liners] would not contribute to the complained device issue.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18276075
• MDR Text Key: 329848835
• Report Number: 1818910-2023-24759
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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 Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN HIP IMPLANT
• Patient Outcome(s): Required Intervention