MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX64OD; HIP ACETABULAR INSERT/LINER

Model Number	1221-40-164
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Weakness (2145); Joint Dislocation (2374); No Code Available (3191)
Date of Event	04/04/2017
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
On may 8, 2017: litigation received.Litigation alleges plaintiff continued to suffer after his revision, including dislocations.Plaintiff was advised to undergo second revision to clear metallosis from damage tissue.In the first revision, cup, liner and head were removed and assuming the stem remained.It was unknown what cup and liner were implanted so they will not be reported at this time.When more information is received, the complaint will be updated.Update aug 30, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges pain.After review of the medical records for mdr reportability, it was stated that the patient was revised to address instability with recurrent dislocations along with the development of some heterotopic ossification.Revision notes reported some clear inflammatory fluid within the joint space and within the trochanteric bursa, synovitis material retrieved from the wound, metallosis, heterotopic bone.It was also reported that the femoral component was stable as revealed on x-ray appropriately sized, positioned, and aligned.Added liner due to the reported metallosis and dislocation.Part and lot information were provided.Product information for head was updated.This complaint was updated on: sep 14, 2017.
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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch 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.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: udi: (b)(4).
Event or Problem Description
Ppf alleges elevated metal ions.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees caused or contributed to the potential event described in this report.No code available use for device revision or replacement.
Event or Problem Description
Pfs alleged weak.After review of medical records patient was revised to addressed instability with recurrent dislocation along with the development of some heterotopic ossification residing within the hip abductors.Operative notes indicated heterotopic bone formation within the adductor musculature.Updated patient harm.Doi: (b)(6) 2016 dor: (b)(6) 2017 right hip 2nd revision.

• Brand Name: ALTRX +4 10D 40IDX64OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6899778
• Report Number: 1818910-2017-25552
• Device Sequence Number: 807954
• Product Code: LPH
• UDI-Device Identifier: 10603295393467
• UDI-Public: 10603295393467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/30/2017

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 Expiration Date: 01/01/2020
• Device Model Number: 1221-40-164
• Device Catalogue Number: 122140164
• Device Lot Number: 629809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 09/19/2018; 02/25/2019; 03/18/2020; 05/06/2021
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 09/20/2018; 03/05/2019; 04/08/2020; 05/07/2021
• 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: 59 YR
• Patient Weight: 98