MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-28-248
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for heterotopic ossification.Limited range of motion.Event is serious and is considered moderate.Event is definitely not related to device and definitely related to procedure.Date of implant:(b)(6) 2019.Date of event: (b)(6) 2019.(right hip).Treatment: radiation and excision of heterotopic ossification.
Event or Problem Description
Medical records received and were reviewed: revision operative notes (b)(6) 2020 indicate the patient received a right total hip surgical excision due to pain, limited range of motion, stiffness and heterotopic ossification.The surgical excision of heterotopic ossification along with irrigation and debridement was completed without indication of complication by the surgeon.No implants were revised.
Additional 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.H10 additional narrative: added: b5 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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, 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 LIP LNR 28IDX48OD
• 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: 10656686
• Report Number: 1818910-2020-21864
• Device Sequence Number: 17648770
• Product Code: LPH
• UDI-Device Identifier: 10603295016021
• UDI-Public: 10603295016021
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1221-28-248
• Device Catalogue Number: 122128248
• Device Lot Number: J1615J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 11/10/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/20/2020; 11/12/2020
• 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: ACTIS COLLARED STD SIZE 4; ALTRX LIP LNR 28IDX48OD; DELTA CER HEAD 12/14 28MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM; ACTIS COLLARED STD SIZE 4; ALTRX LIP LNR 28IDX48OD; DELTA CER HEAD 12/14 28MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64