MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SLIDING CORE 8 MM; IMPLANT

Model Number	99-0028/12F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
A collecting agency filed a claim on behalf of a health insurer in response to a revision surgery resulting from ra2019-2173330.
Additional Manufacturer Narrative
D1, d2, d4 information updated to indicate device information is unknown.The reported event could not be confirmed since no product and no medical records, i.E.X-rays, had been provided.Manufacturing documents could not be reviewed since no lot-no was communicated.No nc/capa had been filed for the item in question.Potential implant exchange had been considered in the risk management file.The labelling informs about protentional adverse effects resp.Their causes.In the case presented an unknown sliding core, 8mm had been revised due to during a procedure of bone removal.A deficiency of the sliding core was not reported.However, more detailed information about the complaint event such as x-rays must be available in order to determine the complete root cause of the complaint event.With available information a real root cause could not be determined.In case substantive information or the item itself becomes available we reserve the right to re-open the investigation with root cause assessment.
Event or Problem Description
A collecting agency filed a claim on behalf of a health insurer in response to a revision surgery resulting from ra2019-2173330.

• Brand Name: UNKNOWN SLIDING CORE 8 MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11896759
• Report Number: 0008031020-2021-00247
• Device Sequence Number: 3633097
• Product Code: NTG
• UDI-Device Identifier: 00886385026985
• UDI-Public: 00886385026985
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 99-0028/12F
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RA2019-2173330
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR