MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-258
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Swelling (2091); Ambulation or Postural Difficulties (2544); Not Applicable (3189)
Date of Event	06/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Complaint description: patient was revised to address suspected infection.Update received 7/17/14.Clinical report received indicating that patient suffered from infection.There is no further information that would affect the mdr decision.Complaint was updated on (b)(6) 2014.(b)(4) is a reopen of (b)(4) due to receipt of the following information: update pfs and medical records received.There were no new allegations added.After review of medical records for mdr reportability it was reported that the patient was revised to address infection.Revision note stated, upon incising through the fascia lata purulent material was encountered over the trochanter.When the hip joint was opened up there was significant intraarticular purulent material encountered.There was chronically infected synovial tissue and capsule.The trunnion and ball of the femur showed corrosive wear.Radio-logical workup including ultrasound and aspiration revealed purulent material in the hip joint.Radio-logical workup including ultrasound and aspiration revealed purulent material in the hip joint.Clinic visit noted, the patient began to have tightness and swelling in her left thigh and she noticed some redness doi: (b)(6) 2011 : dor: (b)(6) 2014; (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
After review of medical records, clinic visit mentioned the patient has a slight antalgic/leg length discrepancy limp on the left.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 LIP LNR 32IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7490365
• Report Number: 1818910-2018-59000
• Device Sequence Number: 11091399
• Product Code: LPH
• UDI-Device Identifier: 10603295016229
• UDI-Public: 10603295016229
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2018

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: 1221-32-258
• Device Catalogue Number: 122132258
• Device Lot Number: E15BJ1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 02/23/2023
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 08/15/2018; 02/24/2023
• Date Device Manufactured: 08/01/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG