MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ASPHERE M SPEC 11/13 36 +0; FEMORAL HEAD

Model Number	1365-31-100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Necrosis (1971); Pain (1994); Tissue Damage (2104); Burning Sensation (2146); Anxiety (2328); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Depression (2361); Confusion/ Disorientation (2553); Not Applicable (3189); No Code Available (3191)
Date of Event	12/04/2017
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
Alleges increased right hip and groin pain which diminished her ability to engage in her activities of daily living.It also alleges metallosis, tissue necrosis, heavy metal poisoning, loss of bone, bodily injury, disability, physical impairment, disfigurement, mental anguish, emotional distress, anxiety and depression.Doi: (b)(6) 2009 : dor: (b)(6) 2017 (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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
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. udi: (b)(4).
Event or Problem Description
Pfs alleges burning sensation.After review of medical records, patient was revised to address heterotopic ossification and trochanteric bursitis.Clinic visits reported of leg length discrepancy.
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. udi: (b)(4).
Event or Problem Description
Ppf alleges elevated metal ions and pseudotumor.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: investigative update: 02 / august / 2021 patient x-ray images have been provided for review.No device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.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.There is otherwise no additional information and no change is required to the initial investigative results.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ASPHERE M SPEC 11/13 36 +0
• Common Device Name: FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7446362
• Report Number: 1818910-2018-57892
• Device Sequence Number: 1950152
• Product Code: JDI
• UDI-Device Identifier: 10603295033370
• UDI-Public: 10603295033370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2018

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 Expiration Date: 01/01/2014
• Device Model Number: 1365-31-100
• Device Catalogue Number: 136531100
• Device Lot Number: 2808498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 02/19/2019; 03/11/2019; 08/04/2021
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 07/27/2018; 02/27/2019; 03/21/2019; 08/05/2021
• 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: 55 YR
• Patient Weight: 59