MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-160
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
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
Primary surgery was a competitor construct done ~15 years ago.On (b)(6) 2021, surgeon revised the acetabular cup and placed in depuy products.Patient fell in (b)(6).No issues.On (b)(6) she dislocated on the 11, 13, & 15.Closed reductions were performed.On the 15th, the surgeon scheduled today's revision.There appeared to be no cause or explanation to the dislocation.Surgeon manipulated the construct prior to revising components and the hip performed well, no dislocation.Surgeon decided to remove the liner implanted in (b)(6) with a constrained liner to prevent any further dislocation.Doi: 2006, dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed and the complaint can¿t be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ALTRX +4 10D 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: 12445852
• Report Number: 1818910-2021-19755
• Device Sequence Number: 5190841
• Product Code: LPH
• UDI-Device Identifier: 10603295016588
• UDI-Public: 10603295016588
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 08/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1221-40-160
• Device Catalogue Number: 122140160
• Device Lot Number: J0653M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 10/12/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/09/2021; 10/15/2021
• 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: ALTRX +4 10D 40IDX60OD.; UNKNOWN HIP FEMORAL HEAD.; ALTRX +4 10D 40IDX60OD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR