MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-460
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/08/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint : (b)(4).Initial reporter occupation: lawyer.(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
Patient presented to e.R.With hip pain.X-rays taken identified a material fracture at the neck of the stem.No patient trauma preceding the failure was reported.Ppf alleges dislocation with closed reduction and elevated metal ions.Added lawyer, law firm, ticked litigation box and an impacted product record for the head and liner was added due to alleged elevated metal ions and dislocation.Doi: (b)(6) 2013 - dor: sep 8, 2015 (left hip) second revision.Please see (b)(4) for the first revision.
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 +4 NEUT 40IDX60OD
• 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: 8872212
• Report Number: 1818910-2019-100439
• Device Sequence Number: 335206
• Product Code: LPH
• UDI-Device Identifier: 10603295016618
• UDI-Public: 10603295016618
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2015

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 1221-40-460
• Device Catalogue Number: 122140460
• Device Lot Number: 377676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 159