MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the surgeon was unsure of the patients original surgery date, who performed the surgery, or where it was done.Patient was suffering from bursitis and the case was boarded as a bursectomy with possible head and liner exchange.Surgeon informed the patient that if he went into the hip capsule he would change the head and liner.Once getting into the hip, he felt the patient would benefit from getting the head and liner exchanged.A 40mm +9 head and 40x58 +4 neutral liner were removed.The surgeon opted to implant a 36x58 +4 neutral liner because he wanted to have a ceramic head as an option.Even though he was told it was off label, he felt the femoral neck was in good enough condition to receive a 36 ceramic.A trail reduction was performed with a 36mm +9.It was found to be stable, so the real head was opened and implanted.The hip was reduced and the closing process began.Doi: unknown - dor: (b)(6) 2021 (right hip).
Additional 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 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.

• Brand Name: ALTRX +4 NEUT 40IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12173120
• Report Number: 1818910-2021-15254
• Device Sequence Number: 935371
• Product Code: LPH
• UDI-Device Identifier: 10603295016601
• UDI-Public: 10603295016601
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1221-40-458
• Device Catalogue Number: 122140458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/13 S-ROM 40MM M SPEC+9; ALTRX +4 NEUT 40IDX58OD; 11/13 S-ROM 40MM M SPEC+9; ALTRX +4 NEUT 40IDX58OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR