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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CROSSLINK ANCHOR PG GLENOID 48; SHOULDER GLENOID
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DEPUY ORTHOPAEDICS, INC. 1818910 CROSSLINK ANCHOR PG GLENOID 48; SHOULDER GLENOID Back to Search Results
Catalog Number 113642026
Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/24/2019
Event Type  Injury  
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 Description
Patient communication received.It was reported that the patient had a shoulder replacement 22 months ago and the plastic piece was loose in his back and it's about 2 months now it was broke off.Doi: none reported - dor: none reported (unk shoulder).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #
=
> (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
=
> null.Device history batch
=
> null.Device history review
=
> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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 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.
 
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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description, product information, and patient codes.
 
Event Description
On (b)(6) 2019, the patient presented for a right shoulder evaluation due to pain following an incident approximately one week prior where the patient felt the right shoulder "pop" while getting out of bed.During the evaluation, the physician reviewed right shoulder ct results from (b)(6) 2019, the results were the following: 1.Failure of the total shoulder arthroplasty with posterior inferior dislocation of the glenoid component.2.Chronic massive rotator cuff tear with retracted supraspinatus and subscaularis tears as well as muscle atrophy.3.Tear of the long head biceps tendon.There is no evidence of revision or invasive treatment to address the issues.
 
Event Description
On (b)(6) 2017, the patient underwent a primary right shoulder arthroplasty due arthritis.Depuy products were implanted with depuy cement.There were no indicated complications during the primary operation.It was indicated that the patient also had a left shoulder replacement implanted on an unknown date in 2010 involving products of an unknown manufacturer.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) was used to capture joint injury, tendon injury, atrophy, and minor injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination, however, review of photos revealed the device was loose.No product contribution to the reported event was identified.Depuy synthes considers the investigation closed.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
Event Description
Ct guided aspiration of the right shoulder occurred on (b)(6) 2019 due to pain ¿ ruled out infection.Results of aspiration were not provided in this set of medical records.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code: appropriate term / code not available (e2402) is used to capture infections (e19).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
On (b)(6) 2020, the patient had a right shoulder arthroscopy, removal of deep shoulder implant, glenoid component to address osteoarthritis, capsulitis, loose glenoid component.During the procedure, the surgeon noted significant inflamed tissue.No surgical complications noted.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
CROSSLINK ANCHOR PG GLENOID 48
Type of Device
SHOULDER GLENOID
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8951705
MDR Text Key185255538
Report Number1818910-2019-102733
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
PMA/PMN Number
K052472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number113642026
Device Lot NumberH76865
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X15 ECC; GLOBAL UNITE STD STEM SZ 12; SMARTSET GHV GENTAMICIN 40G
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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